Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg Next Qualitative, ARCHITECT HBsAg NEXT Confirmatory / Alinity i HBsAg |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 Abbott Park Road DEPT: 09AA BLDG: AP8-1 Abbott Park, IL 60064 |
PMA Number | P210003 |
Supplement Number | S010 |
Date Received | 11/21/2023 |
Decision Date | 12/14/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement a scale up of manufacturing processes for kit components |
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