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Organization (Industry)

Qiagen (Germany)

ClinicalTrials.gov lists Qiagen (Germany) as lead sponsor of 27 trials, counting the companies grouped under it.

DE Manufacturer
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Companies grouped under this page Companies grouped under this page 3 FDA inspection record FDA inspection record 1 FDA recalls FDA recalls 6 FDA import refusals FDA import refusals 1 Manufacturing and distribution sites Manufacturing and distribution sites 2 Companies grouped under this page Companies grouped under this page 3 FDA inspection record FDA inspection record 1 FDA recalls FDA recalls 6 FDA import refusals FDA import refusals 1 Manufacturing and distribution sites Manufacturing and distribution sites 2

Rows recorded per section

15 sections measured, none recorded · 4 counted at group level

Logo Unknown author Unknown author, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.

This page covers Qiagen (Germany) and 3 companies grouped under it: 27 lead-sponsored trials (0 its own, 27 in the grouped companies) and 8 legal-entity registrations (1 its own, 7 in the grouped companies).

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Companies grouped under this page (3)

Shown in this order: most lead trials first.

Companies grouped under this page
Company Lead trials Legal entities
QIAGEN Gaithersburg, Inc 27 0
QIAGEN N.V. 0 6
Qiagen AG 0 1

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
VAI 4

FDA recalls (6)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
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) Class II 2023-08-22
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 Class II 2023-05-19
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 Class II 2023-05-19
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 Class II 2023-05-09
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use. Class II 2018-05-28

Showing 5 of 6 recalls.

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FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
3 2025-10-09

Manufacturing and distribution sites (2)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
QIAGEN, GMBH HILDEN North Rhine-Westphalia, DE FDA
QIAGEN Germantown, US FDA Qiagen

Not on this page

Checked, with nothing recorded for this organization: related companies not grouped here, disease areas, trials by start year as sponsor or collaborator, active development programs, approved assets, sponsor delivery record, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarker capability evidence.

Counted at group level under Qiagen N.V.: journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.