PMA P210003S003
- Device
- ARCHITECT HBsAg Next Qualitative/Next Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P210003
- Supplement
- S003
- Product code
- LOM
- Decision date
- 2022-12-07
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Replacement of a current testing assay with a new equivalent assay.
Current openFDA PMA Record#
- Device
- ARCHITECT HBsAg Next Qualitative/Next Confirmatory
- Applicant
- Abbott Laboratories
- PMA number
- P210003
- Supplement
- S003
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2022-12-07
- Decision code
- OK30
- Date received
- 2022-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of a current testing assay with a new equivalent assay.