PMA P170025S002
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S002
- Product code
- MKT
- Decision date
- 2018-04-10
- Classification
- Hepatitis Viral B Dna Detection
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Transfer manufacturing of kit subcomponents to a new facility.
Current openFDA PMA Record#
- Device
- Aptima HBV Quant Assay
- Applicant
- Hologic, Inc.
- PMA number
- P170025
- Supplement
- S002
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2018-04-10
- Decision code
- OK30
- Date received
- 2018-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer manufacturing of kit subcomponents to a new facility.