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 | 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 | S005 |
Date Received | 06/17/2010 |
Decision Date | 11/23/2010 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BIO-RAD LABORATORIES IN WOODINVILLE, WASHINGTON. |
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