PMA P170025S004
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S004
- Product code
- MKT
- Decision date
- 2018-10-16
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for the transfer of bulk reagent manufacturing to another facility.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S004
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2018-10-16
- Decision code
- APPR
- Date received
- 2018-05-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the transfer of bulk reagent manufacturing to another facility.