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Device | BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | BIO-RAD LABORATORIES 6565 185TH AVE, NE REDMOND, WA 98052 |
PMA Number | P050048 |
Supplement Number | S007 |
Date Received | 02/22/2012 |
Decision Date | 11/13/2012 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODIFICATION OF THE QUALITY CONTROL TESTING SPECIFICATION FOR THE 400 MIU/ML CALIBRATOR IN THE DEVICE. |