Aptima HPV 16 18/45 Genotype Assay
FDA premarket approval P120007/S029 · decided 2022-02-25
Approval details
- PMA number
- P120007
- Supplement
- S029
- Supplement type
- Real-Time Process
- 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
- 2021-12-14
- Decision date
- 2022-02-25
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval to support the addition of the optional use of an automated dishwasher (Miele Dishwasher) to wash Panther Trax shuttle shields, sample racks, and storage racks used with the Aptima HPV assays.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |