QIAGEN GmbH
QIAGEN GmbH holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2026, with 5 FDA device recalls on record.
Top product codes for QIAGEN GmbH
FDA recalls by QIAGEN GmbH
- Z-2665-2023 — therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)
- Z-2245-2023 — QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
- 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 intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
- Z-2215-2023 — QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223
- Z-0274-2018 — QIAamp DSP Virus Kit Cat. No. 60704
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by QIAGEN GmbH
- K254194 — QIAstat-Dx BCID GPF Plus AMR Panel
- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250324 — QIAstat-Dx GI Panel 2 Mini B
- K243813 — QIAstat-Dx GI Panel 2 Mini B&V
- K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel
- K242353 — QIAstat-Dx Respiratory Panel Mini
- K220062 — QIAstat-Dx Gastrointestinal Panel 2
- K233100 — QIAstat-Dx® Respiratory Panel Plus
- K183597 — QIAstat-Dx Respiratory Panel
- K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT
- K113319 — ROTOR-GENE Q MDX
- K113323 — ARTUS INFL A/B RG RT-PCR KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.