PMA P170025S010
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S010
- Product code
- MKT
- Decision date
- 2019-04-28
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for an alternate cleaning recommendation for the sample racks used on the Panther and Tigris instruments.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S010
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2019-04-28
- Decision code
- APPR
- Date received
- 2019-03-18
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate cleaning recommendation for the sample racks used on the Panther and Tigris instruments.