Chrysalis Intelligence · Sponsors · QIAGEN GmbH

QIAGEN GmbH

Hilden, DE · 11 510(k) clearances · 30 PMAs · 4 recalls

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Total clearances
11
2024-05-10 → 2026-09-24
Last 12 months
4
Product codes
5
Most recent
2026-09-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System Class II Microbiology 5 2026-03-09
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 3 2025-08-27
PEN Gram-Negative Bacteria And Associated Resistance Markers Class II Microbiology 1 2026-09-24
PAM Gram-Positive Bacteria And Their Resistance Markers Class II Microbiology 1 2026-08-06
PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System Class II Microbiology 1 2024-10-29
Class III

PMA approvals (30)

Total PMA records
30
Originals + supplements
Distinct product codes
2
First decision
2020-04-03
Most recent
2026-05-06
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-05-06 P180043-S010 QIAGEN therascreen® FGFR RGQ RT-PCR Kit Real-Time Process OWD Somatic Gene Mutation Detection System Unknown
2026-01-23 P010033-S052 QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-11-21 P010033-S051 QuantiFERON-TB Gold Plus Test Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2025-10-22 P190001-S002 therascreen® PIK3CA RGQ PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2025-10-03 P180043-S007 QIAGEN therascreen® FGFR RGQ RT-PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2025-01-16 P110027-S018 therascreen® KRAS RGQ PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2024-12-06 P180043-S008 therascreen FGFR RGQ PCR Kit Normal 180 Day Track No User Fee OWD Somatic Gene Mutation Detection System Unknown
2024-10-23 P180043-S009 therascreen FGFR RGQ RT-PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2024-06-21 P110027-S017 therascreen® KRAS RGQ PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2024-02-09 P010033-S050 QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Test 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2023-12-22 P180043-S006 therascreen FGFR RGQ RT-PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2023-12-15 P010033-S049 QuantiFERON®-TB Gold Plus Test 30-Day Notice NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2023-10-06 P110027-S016 QIAGEN therascreen® KRAS RGQ PCR Kit Special (Immediate Track) OWD Somatic Gene Mutation Detection System Unknown
2023-09-15 P180043-S005 therascreen FGFR RGQ RT-PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2023-06-29 P210002 therascreen PDGFRA RGQ PCR Kit Original OWD Somatic Gene Mutation Detection System Unknown
2023-06-27 P190026-S001 therascreen BRAF V600E RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2023-01-24 P010033-S048 QUANTIFERON®-TB Gold Plus Test Real-Time Process NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2022-12-12 P110027-S013 therascreen KRAS RGQ PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2022-07-11 P110027-S015 therascreen KRAS RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2022-06-17 P110027-S014 therascreen KRAS RGQ PCR Kit Special (Immediate Track) OWD Somatic Gene Mutation Detection System Unknown
2021-12-13 P010033-S047 QuantiFERON®-TB Gold, QuantiFERON®-TB Gold Plus Normal 180 Day Track NCD Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis Unknown
2021-11-16 P180043-S003 therascreen FGFR RGQ RT-PCR Kit Real-Time Process OWD Somatic Gene Mutation Detection System Unknown
2021-07-07 P120022-S022 therascreen EGFR RGQ PCR Kit Real-Time Process OWD Somatic Gene Mutation Detection System Unknown
2021-05-28 P110027-S012 therascreen KRAS RGQ PCR KIT Panel Track OWD Somatic Gene Mutation Detection System Unknown
2020-08-18 P180043-S001 therascreen FGFR RGQ RT-PCR Kit Normal 180 Day Track OWD Somatic Gene Mutation Detection System Unknown
2020-04-15 P190026 therascreen BRAF V600E RGQ PCR Kit Original OWD Somatic Gene Mutation Detection System Unknown
2020-04-03 P190001-S001 therascreen PIK3CA RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2020-04-03 P180043-S002 therascreen FGFR RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2020-04-03 P120022-S021 therascreen EGFR RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
2020-04-03 P110027-S011 therascreen KRAS RGQ PCR Kit 30-Day Notice OWD Somatic Gene Mutation Detection System Unknown
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2023-08-22
DateSeverityStatusRecall # ProductCodeReason
2023-08-22 Class II Ongoing Z-2665-2023 therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection o… — Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false …
2023-05-19 Class II Ongoing Z-2246-2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intende… — Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
2023-05-19 Class II Ongoing Z-2245-2023 QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) sample… — Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
2023-05-09 Class II Ongoing Z-2215-2023 QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C… — If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that l…
Filings

All 510(k) clearances (11)

Date K-number Device Code Class Specialty
2026-09-24 K262168 QIAstat-Dx BCID GN Plus AMR Panel PEN Class II Microbiology
2026-08-06 K254194 QIAstat-Dx BCID GPF Plus AMR Panel PAM Class II Microbiology
2026-03-09 K254032 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B PCH Class II Microbiology
2025-10-22 K252329 QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B PCH Class II Microbiology
2025-08-27 K250080 QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini QOF Class II Microbiology
2025-02-28 K250324 QIAstat-Dx GI Panel 2 Mini B PCH Class II Microbiology
2025-01-08 K243813 QIAstat-Dx GI Panel 2 Mini B&V PCH Class II Microbiology
2024-10-29 K242256 QIAstat-Dx Meningitis/Encephalitis (ME) Panel PLO Class II Microbiology
2024-10-25 K242353 QIAstat-Dx Respiratory Panel Mini QOF Class II Microbiology
2024-05-31 K220062 QIAstat-Dx Gastrointestinal Panel 2 PCH Class II Microbiology
2024-05-10 K233100 QIAstat-Dx® Respiratory Panel Plus QOF Class II Microbiology
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence