Aptima HPV Assay
FDA premarket approval P100042/S028 · decided 2020-01-21
Approval details
- PMA number
- P100042
- Supplement
- S028
- Supplement type
- Real-Time Process
- 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
- 2019-12-23
- Decision date
- 2020-01-21
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |