PMA P170025S008
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S008
- Product code
- MKT
- Decision date
- 2019-03-08
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Implementation of additional in-process testing and associated specifications for lyophilized kit reagents.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S008
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of additional in-process testing and associated specifications for lyophilized kit reagents.