PMA P120007S033
- Device
- Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S033
- Product code
- OYB
- Decision date
- 2025-10-07
- Classification
- Microbiology
- Generic name
- Kit, rna detection, human papillomavirus
- Approval order statement
- to adjust raw material test method
Current openFDA PMA Record#
- Device
- Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass
- Applicant
- Gen-Probe Incorporated
- PMA number
- P120007
- Supplement
- S033
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2025-10-07
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to adjust raw material test method