PMA P080023S028
- Device
- Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls
- Applicant
- Abbott Laboratories
- PMA number
- P080023
- Supplement
- S028
- Product code
- LOM
- Decision date
- 2019-03-06
- 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 the migration of the ARCHITECT CORE Reagent Kit, ARCHITECT CORE Calibrator, ARCHITECT CORE Controls onto the Alinity i Analyzer.
Current openFDA PMA Record#
- Device
- Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls
- Applicant
- Abbott Laboratories
- PMA number
- P080023
- Supplement
- S028
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-03-06
- Decision code
- APPR
- Date received
- 2017-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of the ARCHITECT CORE Reagent Kit, ARCHITECT CORE Calibrator, ARCHITECT CORE Controls onto the Alinity i Analyzer.