APTIMA HPV ASSAY
FDA premarket approval P100042/S005 · decided 2015-04-01
Approval details
- PMA number
- P100042
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- APTIMA HPV ASSAY
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2015-03-04
- Decision date
- 2015-04-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- SCALE-UP OF A BULK SOLUTION, INCREASE IN THE BULK HOLD TIME, AND QUALIFICATION OF A NEW MANUFACTURING FILLING SYSTEM.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |