PMA P080026S025
- Device
- Abbott RealTime HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P080026
- Supplement
- S025
- Product code
- MKT
- Decision date
- 2025-04-11
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- a new vendor test method, test site, and test sensitivity used for the assay reagents
Current openFDA PMA Record#
- Device
- Abbott RealTime HBV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P080026
- Supplement
- S025
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2025-04-11
- Decision code
- OK30
- Date received
- 2025-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vendor test method, test site, and test sensitivity used for the assay reagents