PMA P050051S033
- Device
- Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S033
- 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 migration of the ARCHITECT AUSAB assay, ARCHITECT AUSAB Calibrators and ARCHITECT AUSAB Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.
Current openFDA PMA Record#
- Device
- Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls
- Applicant
- Abbott Laboratories, Inc.
- PMA number
- P050051
- Supplement
- S033
- 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 migration of the ARCHITECT AUSAB assay, ARCHITECT AUSAB Calibrators and ARCHITECT AUSAB Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.