Aptima HPV 16 18/45 Genotype Assay
FDA premarket approval P120007/S011 · decided 2018-02-23
Approval details
- PMA number
- P120007
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aptima HPV 16 18/45 Genotype Assay
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2017-09-01
- Decision date
- 2018-02-23
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the use of the Aptima HPV 16 18/45 Genotype Assay on Panther Systems equipped with a Panther Fusion Module. The changes required for addition of the Panther Fusion Module that are subject to this approval include reconfiguration of the Panther System hardware, and updates to the Panther System and Aptima HPV 16 18/45 Genotype Assay software.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |