PMA P050051S032
- Device
- ABBOTT ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S032
- Product code
- LOM
- Decision date
- 2016-12-09
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- Approval for re-standardization of the assay to the WHO 2nd International Standard and changes to the dilution protocol for the Abbott ARCHITECT AUSAB which uses a new component, the ARCHITECT AUSAB Specimen Diluent.
Current openFDA PMA Record#
- Device
- ABBOTT ARCHITECT AUSAB
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S032
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2016-12-09
- Decision code
- APPR
- Date received
- 2016-08-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for re-standardization of the assay to the WHO 2nd International Standard and changes to the dilution protocol for the Abbott ARCHITECT AUSAB which uses a new component, the ARCHITECT AUSAB Specimen Diluent.