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Data / Medical devices / Germany / Qiagen, GMBH

Qiagen, GMBH: FDA-registered device maker in HILDEN North Rhine-Westphalia, Germany, 7 510(k) clearances and 6 PMA approvals

Qiagen, GMBH is registered with the FDA (registration 3004013603) in HILDEN North Rhine-Westphalia, Germany. It lists 19 device types. The FDA files 7 510(k) clearances and 6 PMA approvals under its listings, the newest dated August 6, 2026. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Qiagen, GMBH
FDA registration number
3004013603
Address
Qiagen Strasse 1, HILDEN North Rhine-Westphalia, Germany, 40724
Owner or operator
QIAGEN, GmbH (9065957)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
July 5, 2005
Registered through
2026
Brand names listed
BK Virus Positive Control, BK Virus Primer ASR, BK Virus Probe ASR, Buffer ACL, Buffer ASL, Buffer ATL, Buffer AVL, Deparaffinization solution and more

Devices it lists

DeviceProduct codeClassRoleSource
C. Difficile Toxin Gene Amplification AssayOZN2Specification developeraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufacturer, Specification developeraccessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical UseJJQ1Specification developeraccessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative AssayPAB2Manufactureraccessdata.fda.gov
Droplet Digital Pcr SystemPHG2Manufacturer, Specification developeraccessdata.fda.gov
Fungal Organisms, Nucleic Acid-Based AssayPEO2Specification developeraccessdata.fda.gov
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemPCH2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Gram-Negative Bacteria And Associated Resistance MarkersPEN2Specification developeraccessdata.fda.gov
Gram-Positive Bacteria And Their Resistance MarkersPAM2Specification developeraccessdata.fda.gov
Jak2 Gene Mutation Detection TestPSU2Manufactureraccessdata.fda.gov
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection SystemPLO2Specification developeraccessdata.fda.gov
Multi-Analyte Controls UnassayedOHQ1Manufactureraccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Manufactureraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNManufactureraccessdata.fda.gov
Reagents, Specific, AnalyteMVU1Contract manufacturer, Manufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Manufacturer, Specification developeraccessdata.fda.gov
Somatic Gene Mutation Detection SystemOWD3Manufactureraccessdata.fda.gov
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic TestNTW2Contract manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 6, 2026K254194QIAstat-Dx BCID GPF Plus AMR PanelPAMSubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov
October 29, 2024K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLOSubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov
May 31, 2024K220062QIAstat-Dx Gastrointestinal Panel 2PCHSubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov
May 10, 2024K233100QIAstat-Dx® Respiratory Panel PlusQOFSubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov
March 27, 2017DEN160028ipsogen JAK2 RGQ PCR KitPSUUnknownQiagen, Inc.accessdata.fda.gov
April 4, 2014K133936ARTUS C. DIFFICILE QS-RGQ MDX KITOZNSubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov
February 6, 2012K113319ROTOR-GENE Q MDXOOISubstantially EquivalentQIAGEN GmbHaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 29, 2023P210002therascreen PDGFRA RGQ PCR KitOWD0June 29, 2023accessdata.fda.gov
April 15, 2020P190026therascreen BRAF V600E RGQ PCR KitOWD1June 27, 2023accessdata.fda.gov
May 24, 2019P190001therascreen PIK3CA RGQ PCR KitOWD2October 22, 2025accessdata.fda.gov
April 12, 2019P180043therascreen FGFR RGQ RT-PCR KitOWD9May 6, 2026accessdata.fda.gov
June 2, 2014P130027ARTUS CMV RGQ MDX KITPAB6September 26, 2018accessdata.fda.gov
July 6, 2012P110030THERASCREEN KRAS RGQ PCR KITOWD0July 6, 2012accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 22, 202392991Class IIOngoingtherascreen 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)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 negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalidaccessdata.fda.gov
May 19, 202392609Class IIOngoingQIAstat-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 acIdentified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeatedaccessdata.fda.gov
May 9, 202392540Class IIOngoingQIAstat-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, CIf 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 lead to a run abortion will occur and no results will be reportedaccessdata.fda.gov
July 22, 201778646Class IITerminatedQIAamp DSP Virus Kit Cat. No. 60704Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.accessdata.fda.gov

Compare with other makers

Updated August 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.