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 Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. DEPT 09V6, BLDG. AP5-2 ABBOTT PARK, IL 60064-6088 |
PMA Number | P110029 |
Supplement Number | S027 |
Date Received | 06/27/2018 |
Decision Date | 07/18/2018 |
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 Change a quality control standard and specifications used to qualify kit subcomponents. |
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