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 | AXSYM ANTI-HCV |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P970027 |
Supplement Number | S016 |
Date Received | 09/16/2011 |
Decision Date | 10/19/2011 |
Withdrawal Date
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11/08/2013 |
Product Code |
MZO |
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 RELOCATION OF A FORMULATION ROOM FOR THE LYOPHILIZATION OF ALKALINE-TREATED CASEIN USED IN THE DEVICE. |
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