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 | S015 |
Date Received | 09/07/2011 |
Decision Date | 10/07/2011 |
Withdrawal Date
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11/08/2013 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL FOR THE AXSYM ANTI-HCV, ARCHITECT CORE-M AND AXSYM CORE. |
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