PMA P060035S026
- Device
- Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S026
- Product code
- LOM
- Decision date
- 2019-06-20
- 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 CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, ARCHITECT CORE-M 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-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S026
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2019-06-20
- Decision code
- APPR
- Date received
- 2018-06-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for migration of the ARCHITECT CORE-M Reagent Kit, ARCHITECT CORE-M Calibrators, ARCHITECT CORE-M Controls onto the Alinity i Analyzer. The manufacture of the Alinity i analyzer would be done at a new contract manufacturer, Sanmina, Singapore.