Chrysalis Intelligence · Product Codes · MZO

MZO · Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Microbiology · 3 clearances · 2 unique sponsors

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Device class
Class II
Regulation 866.3169
Total clearances
3
2023-01-04 → 2026-09-23
Last 12 months
2
Unique sponsors
2
Classification details
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.3169
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Abbott Laboratories 2 2 2026-09-23
Roche Diagnostics 1 0 2023-01-04
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87522 CPT — High Hepatitis C virus antibody detection by enzyme immunoassay or ELISA
Class III

PMA records in this code (21)

DatePMA #SponsorTrade nameType
2021-12-15 P050042-S047 Abbott Laboratories, Inc. ARCHITECT Anti-HCV / Alinity i Anti-HCV 30-Day Notice
2021-12-06 P050042-S046 Abbott Laboratories, Inc. ARCHITECT Anti-HCV (LN 1L79) 30-Day Notice
2021-08-10 P190011-S004 DiaSorin, Inc. LIAISON XL MUREX HCV Ab, LIAISON XL MUREX Control HCV Ab Real-Time Process
2021-04-27 P030056-S020 Siemens Healthcare Diagnostics Atellica IM Hepatitis C (aHCV) Assay 30-Day Notice
2021-04-22 P050042-S045 Abbott Laboratories, Inc. ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit Real-Time Process
2021-04-20 P080027-S039 OraSure Technologies, Inc. OraQuick HCV Rapid Antibody Test 30-Day Notice
2021-03-11 P030056-S019 Siemens Healthcare Diagnostics ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC) Real-Time Process
2021-02-25 P080027-S038 OraSure Technologies, Inc. OraQuick HCV Rapid Antibody Test 30-Day Notice
2020-10-16 P080027-S037 OraSure Technologies, Inc. OraQuick HCV Rapid Antibody Test 30-Day Notice
2020-08-28 P050042-S044 Abbott Laboratories, Inc. ARCHITECT Anti-HCV, Alinity i Anti-HCV 30-Day Notice
2020-08-25 P030056-S018 Siemens Healthcare Diagnostics ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials 30-Day Notice
2020-08-07 P010021-S033 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator 30-Day Notice
2020-08-06 P190011-S002 DiaSorin, Inc. LIAISON XL MUREX HCV Ab Real-Time Process
2020-06-21 P030056-S017 Siemens Healthcare Diagnostics ADVIA Centaur HCV, and Atellica HCV 30-Day Notice
2020-06-05 P050042-S040 Abbott Laboratories, Inc. Alinity i Anti-HCV Reagent Kit Real-Time Process
2020-05-23 P050042-S042 Abbott Laboratories, Inc. ARCHITECT Anti-HCV Normal 180 Day Track No User Fee
2020-05-23 P050042-S041 Abbott Laboratories, Inc. Alinity i Anti-HCV Normal 180 Day Track No User Fee
2020-04-29 P050042-S043 Abbott Laboratories, Inc. ARCHITECT Anti-HCV and Alinity i Anti-HCV 30-Day Notice
2020-04-08 P190011-S001 DiaSorin, Inc. LIAISON XL MUREX HCV Ab Real-Time Process
2020-04-03 P030056-S016 Siemens Healthcare Diagnostics Atellica IM Hepatitis C (aHCV) Assay 30-Day Notice
2020-03-19 P030056-S015 Siemens Healthcare Diagnostics ADVIA Centaur and Atellica IM HCV 30-Day Notice
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-23 K262156 Abbott Laboratories Anti-HCV Next
2026-04-28 K252424 Abbott Laboratories Anti-HCV Next
2023-01-04 K221693 Roche Diagnostics Elecsys Anti-HCV II (08837031190)
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence