PMA P170025S023
- Device
- Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S023
- Product code
- MKT
- Decision date
- 2025-10-07
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- to adjust raw material test method
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S023
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2025-10-07
- Decision code
- OK30
- Date received
- 2025-09-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to adjust raw material test method