VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
FDA premarket approval P880009/S003 · decided 1990-02-01
Approval details
- PMA number
- P880009
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Qiagen, Inc.
- Date received
- 1989-09-18
- Decision date
- 1990-02-01
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Gaithersburg, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |