PMA P170025S014
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S014
- Product code
- MKT
- Decision date
- 2020-01-21
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S014
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2020-01-21
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments.