- Device
- Alinity i Anti-HBc lgM
- Applicant
- Abbott Laboratories
- PMA number
- P060035
- Supplement
- S029
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2020-05-23
- Decision code
- APPR
- Date received
- 2020-03-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Abbott Laboratories, 1915 Hurd Drive, Irving, Texas 75038, USA for the production of the Alinity i System.