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 & ARCHITECT HBSAG CONFIRMATORY ASSAYS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064 |
PMA Number | P060007 |
Supplement Number | S011 |
Date Received | 03/01/2011 |
Decision Date | 03/30/2011 |
Withdrawal Date
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01/09/2014 |
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 TEST METHOD CHANGE FOR QUANTITATING ANTI-D AND ANTI-Y MONOCLONAL ANTIBODIES WHICH ARE USED IN THE TESTING OF THE RECOMBINANT HBSAG SUBTYPE AD (CODE 98034) AND HBSAG SUBTYPE AY (CODE 98035) ANTIGENS USED IN THE ARCHITECT HBSAG AND HBSAG CONFIRMATORY ASSAYS. |
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