PMA P100042S039
- Device
- Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S039
- 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 Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S039
- 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