Qiagen Gaithersburg, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Qiagen Gaithersburg, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAQ | Kit, Dna Detection, Human Papillomavirus | 1 | 0 |
Review panels
- Microbiology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890064 | PMA | VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT | 1991-03-11 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2013-01-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Qiagen Gaithersburg, Inc. is the lead sponsor of 12 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06645236: DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit (Recruiting, started 2023-12-22)
- NCT05305534: QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study (Completed, started 2023-12-01)
- NCT05733559: QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study (Completed, started 2023-02-23)
- NCT05155553: QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study (Completed, started 2022-05-04)
- NCT05162547: Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay (Completed, started 2022-03-11)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- QIAGEN GmbH (16 510(k)s)
- QIAGEN Manchester, Ltd. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Qiagen Gaithersburg, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Qiagen Gaithersburg, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Qiagen Gaithersburg, Inc.?
The most frequent FDA product codes under this applicant name are MAQ (Kit, Dna Detection, Human Papillomavirus, 1).
Next steps
- See all 0 Qiagen Gaithersburg, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MAQ, Qiagen Gaithersburg, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.