Chrysalis Intelligence · Sponsors · DiaSorin, Inc.

DiaSorin, Inc.

Stillwater, MN, US · 14 510(k) clearances · 215 PMAs · 4 recalls

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Total clearances
14
2020-01-29 → 2026-06-04
Last 12 months
2
Product codes
10
Most recent
2026-06-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LOL Hepatitis A Test (Antibody And Igm Antibody) Class II Microbiology 3 2022-12-09
LSR Reagent, Borrelia Serological Reagent Class II Microbiology 3 2021-02-18
LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Class II Microbiology 1 2026-06-04
SGW Device To Detect Antibodies To Hepatitis D Virus Class II Immunology 1 2025-12-23
LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster Class II Microbiology 1 2023-10-27
NXO Calprotectin, Fecal Class II Immunology 1 2022-07-26
QPS Immunoassay For Host Biomarkers Of Infection Class II Microbiology 1 2022-07-14
DBF Ferritin, Antigen, Antiserum, Control Class II Immunology 1 2021-09-14
CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone Class I Clinical Chemistry 1 2020-10-15
CGN Acid, Folic, Radioimmunoassay Class II Clinical Chemistry 1 2020-05-06
Class III

PMA approvals (215)

Total PMA records
215
Originals + supplements
Distinct product codes
7
First decision
2020-01-02
Most recent
2026-09-24
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-24 P180047-S046 LIAISON® QuantiFERON®-TB Gold Plus II. 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2026-08-27 P180047-S045 LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus II; LIAISON C Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2026-08-27 P180047-S043 LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold Plus II; LIAI Normal 180 Day Track NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2026-08-18 P220034-S010 LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus Normal 180 Day Track MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2026-06-24 P250039-S001 LIAISON® Biotrin Parvovirus B19 IgM Plus, LIAISON® Biotrin Control Parvovirus B19 IgM Plus 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2026-06-24 P220034-S011 LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2026-05-26 P180047-S044 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2026-05-07 P250039 LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus Original MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2026-01-26 P180047-S039 LIAISON QuantiFERON TB Gold Plus II; LIAISON Control QuantiFERON TB Gold Plus II Normal 180 Day Track NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-12-19 P220034-S008 LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-12-19 P180047-S041 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-10-10 P220034-S007 LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus Real-Time Process MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-10-10 P190017-S026 LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-10-10 P180049-S021 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-10-10 P180048-S021 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-10-10 P180047-S037 LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-10-10 P180045-S020 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-10-10 P180039-S023 LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-10-10 P180038-S025 LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-08-28 P190017-S028 LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-08-28 P180047-S040 LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON-TBGold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-08-28 P180038-S027 LIAISON® Murex Anti-HBc and LIAISON® MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-08-21 P190017-S027 LIAISON® MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg Qual and LIAISON® MUREX HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-08-21 P180047-S038 LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-08-21 P180038-S026 LIAISON® MUREX Anti-HBc and LIAISON® MUREX Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-06-04 P180047-S035 LIAISON QuantiFERON -TB Gold Plus and LIAISON Control QuantiFERON -TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-06-04 P180038-S024 LIAISON MUREX Anti-HBc and LIAISON MUREX Control Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P220034-S004 LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus Real-Time Process MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-04-25 P190017-S023 LIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P180049-S018 LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P180048-S018 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P180047-S032 LIAISON QuantiFERON - TB Gold Plus, LIAISON XL Control QuantiFERON - TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-04-25 P180045-S017 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P180039-S020 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-25 P180038-S021 LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-16 P190017-S018 LIAISON® XL Murex HBsAg (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) and LIAISON® XL Murex HBsAg Confirmat Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P220034-S006 LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-04-10 P190017-S025 LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P180049-S020 LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P180048-S020 LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P180047-S034 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-04-10 P180045-S019 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P180039-S022 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-04-10 P180038-S023 LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P220034-S005 -LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-02-25 P190017-S024 LIAISON XL MUREX HBsAg Qual; LIAISON XL MUREX Control HBsAg Qual; LIAISON XL MUREX HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P180049-S019 LIAISON XL MUREX Anti-HBe; LIAISON XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P180048-S019 LIAISON XL MUREX HBeAg; vLIAISON XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P180047-S033 LIAISON QuantiFERON-TB Gold Plus; LIAISON Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-02-25 P180045-S018 LIAISON XL MUREX HBc IgM; LIAISON XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P180039-S021 LIAISON XL MUREX Anti-HBs; LIAISON XL MUREX Control Anti-HBs; LIAISON XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-02-25 P180038-S022 LIAISON MUREX Anti-HBc; LIAISON MUREX Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P970055-S024 Parvovirus B 19 IgM Enzyme Immunoassay 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2025-01-06 P970054-S022 Parvovirus B 19 IgG Enzyme Immunoassay 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-01-06 P220034-S003 LIAISON Biotrin Parvovirus B19 lgG Plus and LIAISON Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2025-01-06 P190017-S022 LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P180049-S017 LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P180048-S017 LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P180047-S031 LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-01-06 P180045-S016 LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P180039-S019 LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2025-01-06 P180038-S020 LIAISON XL Murex Anti-HBc and LIAISON XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-12-19 P190017-S021 LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual and LIAISON XL MUREX HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-12-13 P180047-S030 LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2024-10-11 P180047-S028 LIAISON QuantiFERON-TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2024-09-05 P180047-S027 LIAISON® QuantiFERON®-TB Gold Plus, LIAISON® Control QuantiFERON®-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2024-07-12 P970055-S023 Parvovirus B19 IgM Enzyme Immunoassay 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2024-07-12 P970054-S021 Parvovirus B19 IgG Enzyme Immunoassay 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2024-07-12 P220034-S002 LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2024-07-12 P190017-S020 LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-12 P180049-S016 LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-12 P180048-S016 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-12 P180047-S026 LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2024-07-12 P180045-S015 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-12 P180039-S018 LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL Murex Anti-HBs Verifier 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-07-12 P180038-S019 LIAISON® XL Murex Anti-HBc, LIAISON® XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P220034-S001 LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2024-06-04 P190017-S019 LIAISON XL MUREX HBsAg Qual and LIAISON XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P180049-S015 LIAISON XL MUREX anti-HBe, LIAISON XL MUREX Control anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P180048-S015 LIAISON XL MUREX HBeAg and LIAISON XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P180047-S025 LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2024-06-04 P180045-S014 LIAISON XL MUREX HBc IgM and LIAISON XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P180039-S016 LIAISON XL Murex Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifier 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-06-04 P180038-S018 LIAISON XL Murex Anti-HBc and LIAISON XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-04-22 P180038-S017 LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2024-03-29 P220034 LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus Original MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2023-11-08 P190017-S017 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P180049-S014 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P180048-S014 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P180047-S024 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2023-11-08 P180045-S013 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P180039-S015 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-11-08 P180038-S016 LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-10-05 P190017-S016 LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg. 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P190017-S015 LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P180049-S013 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P180048-S012 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P180047-S023 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2023-09-28 P180045-S012 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P180039-S014 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-09-28 P180038-S015 LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-08-22 P190017-S014 LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-07-18 P180047-S019 LIAISON QuantiFERON-TB Gold Plus Normal 180 Day Track NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2023-06-07 P190017-S012 LIAISON® XL MUREX HBsAg Qual Assay Special (Immediate Track) LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-05-11 P190017-S011 LIAISON® XL Murex HBsAg Qual and LIAISON® XL Murex Control HBsAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-04-13 P190017-S009 LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX HBsAg Confirmatory Test Normal 180 Day Track LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2023-02-01 P180047-S021 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-12-21 P190017-S008 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-21 P180049-S010 LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-21 P180048-S010 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-21 P180047-S020 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-12-21 P180045-S010 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-21 P180039-S012 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-21 P180038-S013 LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-08 P190017-S010 LIAISON® XL MUREX HBsAg Confirmatory 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-08 P180049-S011 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice — — —
2022-12-08 P180048-S011 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-08 P180047-S022 LIAISON® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-12-08 P180045-S011 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-12-08 P180039-S013 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice — — —
2022-12-08 P180038-S014 LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-08-11 P180047-S018 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-07-08 P180047-S017 LIAISON® QuantiFERON TB-Gold Plus assay and Control Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-06-23 P190017-S006 LIAISON® XL MUREX HBsAg Qual assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-06-23 P180049-S009 LIAISON® XL MUREX Anti-HBe assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-06-23 P180048-S009 LIAISON® XL MUREX HBeAg assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-06-23 P180047-S016 LIAISON® QuantiFERON TB-Gold Plus assay and Control Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-06-23 P180045-S009 LIAISON® XL MUREX HBc IgM assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-06-23 P180039-S011 LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-06-23 P180038-S012 LIAISON® XL MUREX Anti-HBc assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P190017-S005 LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P180049-S008 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P180048-S008 LIAISON® XL MUREX HBeAg and LIAISON00 XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P180047-S015 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-05-06 P180045-S008 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P180039-S010 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-06 P180038-S011 LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P190017-S004 LIAISON® XL MUREX HBsAg Qual assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P180049-S007 LIAISON® XL MUREX Anti-HBe assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P180048-S007 LIAISON® XL MUREX HBeAg assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P180047-S014 LIAISON® QuantiFERON TB-Gold Plus assay and Control Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-05-05 P180045-S007 LIAISON® XL MUREX HBc lgM assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P180039-S009 LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-05-05 P180038-S010 LIAISON®XL MUREX Anti-HBc assay and Control Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P190017-S003 LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P180049-S003 LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P180048-S003 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P180047-S011 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® Control QuantiFERON-TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-01-21 P180045-S003 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P180039-S005 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2022-01-21 P180038-S006 LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBC Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-27 P180049-S005 LIAISON® XL Murex Anti-HBe and LIAISON® XL Murex Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-27 P180048-S005 LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-27 P180045-S005 LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-27 P180039-S007 LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-27 P180038-S008 LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P990045-S029 ETI-AB-COREK PLUS assay 30-Day Notice — — —
2021-12-21 P990044-S029 ETI-CORE-IGMK PLUS assay 30-Day Notice — — —
2021-12-21 P990043-S032 ETI-EBK PLUS assay 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P990042-S028 ETI-AB-AUK PLUS assay 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P990041-S031 ETI-AB-EBK PLUS assay 30-Day Notice — — —
2021-12-21 P990038-S032 ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P970055-S022 Parvovirus B19 IgM Enzyme Immunoassay 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2021-12-21 P970054-S020 Parvovirus B19 IgG Enzyme Immunoassay 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2021-12-21 P180049-S004 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P180048-S004 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P180047-S012 LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® Control QuantiFERON® - TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-12-21 P180045-S004 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P180039-S006 LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-21 P180038-S007 LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P180049-S006 LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P180048-S006 LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P180047-S013 LIAISON® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-12-17 P180045-S006 LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P180039-S008 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-12-17 P180038-S009 LIAISON® XL MUREX anti-HBc and LIAISON® XL MUREX Control anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-11-16 P180047-S009 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus Normal 180 Day Track NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-09-17 P180047-S008 LIAISON QuantiFERON-TB Gold Plus and LIAISON Control QuantiFERON-TB Gold Plus Normal 180 Day Track No User Fee NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-08-10 P190017-S002 LIAISON XL MUREX HBsAg Qual, LIAISON XL MUREX Control HBsAg Qual Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-08-10 P190011-S004 LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab Real-Time Process MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology
2021-08-10 P180049-S002 LIAISON XL MUREX Anti-HBe, LIAISON XL MUREX Control Anti-HBe Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-08-10 P180048-S002 LIAISON XL MUREX HBeAg, LIAISON XL MUREX Control HBeAg Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-08-10 P180047-S010 LIAISON QuantiFERON-TB Gold Plus, LIAISON XL Control QuantiFERON-TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-08-10 P180045-S002 LIAISON XL MUREX HBc IgM, LIAISON XL MUREX Control HBc IgM Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-08-10 P180039-S004 LIAISON XL MUREX Anti-HBs, LIAISON XL MUREX Control Anti-HBs and LIAISON XL MUREX Anti-HBs Verifiers Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2021-08-10 P180038-S005 LIAISON XL MUREX Anti-HBc, LIAISON XL MUREX Control Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-11-25 P180047-S006 LIAISON QuantiFERON-TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-10-26 P180047-S001 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus 135 Review Track For 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-08-29 P190017 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test Original LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-29 P180049 LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe Original SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology
2020-08-29 P180048 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg Original LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-29 P180045 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM Original SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology
2020-08-13 P990045-S028 ETI-AB-COREK PLUS assay 30-Day Notice — — —
2020-08-13 P990044-S028 ETI-CORE-IGMK PLUS assay 30-Day Notice — — —
2020-08-13 P990043-S031 ETI-EBK PLUS assay 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-13 P990042-S027 ETI-AB-AUK PLUS assay 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-13 P990041-S030 ETI-AB-EBK PLUS assay 30-Day Notice — — —
2020-08-13 P990038-S031 ETI-MAK-2 PLUS and HBsAg Confirmatory Test assays 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-13 P970055-S021 Parvovirus B19 IgM Enzyme Immunoassay 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2020-08-13 P970054-S019 Parvovirus B19 IgG Enzyme Immunoassay 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2020-08-13 P180047-S005 LIAISON QuantiFERON - TB Gold Plus and LIAISON Control QuantiFERON - TB Gold Plus 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-08-13 P180039-S002 LIAISON XL Murex Anti-HBs, LIAISON XL Murex Control Anti-HBs and LIAISON XL Murex Anti-HBs Verifiers 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-13 P180038-S003 LIAISON XL Murex Anti-HBc and LIAISON XL Murex Control Anti-HBc 30-Day Notice LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-06 P190011-S002 LIAISON XL MUREX HCV Ab Real-Time Process MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology
2020-08-06 P180047-S004 LIAISON QuantiFERON - TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-08-06 P180039-S001 LIAISON XL MUREX Anti-HBs Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-08-06 P180038-S002 LIAISON XL MUREX Anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-07-23 P180047-S003 LIAISON QuantiFERON TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-04-21 P970055-S020 Parvovirus B19 IgM Enzyme Immunoassay 30-Day Notice MYM Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm Unknown
2020-04-21 P970054-S018 Parvovirus B19 IgG Enzyme Immunoassay 30-Day Notice MYL Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg Unknown
2020-04-08 P190011-S001 LIAISON XL MUREX HCV Ab Real-Time Process MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Microbiology
2020-04-08 P180047-S002 LIAISON QuantiFERON - TB Gold Plus Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2020-04-08 P180038-S001 LIAISON XL MUREX anti-HBc Real-Time Process LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) Microbiology
2020-02-21 P180039 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers Original SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology
2020-01-02 P180038 LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc Original SEI Qualitative And Quantitative Hepatitis B Virus Antibody Assays Microbiology
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
3
Most recent
2024-11-07
DateSeverityStatusRecall # ProductCodeReason
2024-11-07 Class II Ongoing Z-0677-2025 DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens — Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISO…
2023-12-13 Class II Ongoing Z-0815-2024 DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 — DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAI…
2020-11-23 Class II Terminated Z-1342-2021 LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative… — Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
2020-07-17 Class II Ongoing Z-2936-2020 Parvovirus B19 IgG EIA kit Part No. V519IGUS — Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
Filings

All 510(k) clearances (14)

Date K-number Device Code Class Specialty
2026-06-04 K260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX LOM Class II Microbiology
2025-12-23 DEN250032 LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) SGW Class II Immunology
2023-10-27 K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HT LFY Class II Microbiology
2022-12-09 K223403 LIAISON Anti-HAV; LIAISON XS LOL Class II Microbiology
2022-07-26 K213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus NXO Class II Immunology
2022-07-14 K213936 LIAISON MeMed BV, LIAISON MeMed BV Control Set QPS Class II Microbiology
2021-09-14 K193650 LIAISON Ferritin DBF Class II Immunology
2021-02-18 K202574 LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus LSR Class II Microbiology
2021-02-18 K202573 LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus LSR Class II Microbiology
2021-02-09 K210272 LIAISON Anti-HAV LOL Class II Microbiology
2020-10-15 K201908 LIAISON Testosterone xt CDZ Class I Clinical Chemistry
2020-05-06 K192586 LIAISON® Folate CGN Class II Clinical Chemistry
2020-03-02 K193532 LIAISON Anti-HAV Assay LOL Class II Microbiology
2020-01-29 K193051 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set LSR Class II Microbiology
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence