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 | BIO-RAD MONOLISA ANTI-HBS EIA |
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 | S002 |
Date Received | 09/30/2008 |
Decision Date | 03/12/2010 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MONOLISA ANTI-HBS EIA PACKAGE INSERT IN ORDER TO ADD THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, WITH UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED. |
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