PMA P170025S007
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S007
- Product code
- MKT
- Decision date
- 2019-02-28
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Approval for an alternate cleaning method for the samples racks used on the Panther, Panther Fusion, and Tigris instruments.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S007
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate cleaning method for the samples racks used on the Panther, Panther Fusion, and Tigris instruments.