APTIMA HPV 16 18/45 GENETYPE ASSAY
FDA premarket approval P120007/S002 · decided 2014-04-29
Approval details
- PMA number
- P120007
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APTIMA HPV 16 18/45 GENETYPE ASSAY
- Generic name
- Kit, rna detection, human papillomavirus
- Applicant
- Gen-Probe Incorporated
- Date received
- 2014-04-17
- Decision date
- 2014-04-29
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- OYB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| APTIMA TRICHOMONAS VAGINALIS ASSAY (DEN110012) | Gen-Probe Incorporated | 2011-04-19 |