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-HBC IGM EIA |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Bio-Rad Laboratories, Inc. 6565 185TH AVE., N.E. REDMOND, WA 98052 |
PMA Number | P060034 |
Supplement Number | S002 |
Date Received | 09/30/2008 |
Decision Date | 02/20/2009 |
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 AN AMENDMENT TO THE PACKAGE INSERT WITH THE ADDITION OF THE STATEMENT THAT ALLOWS STORAGE OF THE WORKING CONJUGATE SOLUTION AT ROOM TEMPERATURE FOR 30 HOURS, UP TO 10 CYCLES OF 3 HOURS AT ROOM TEMPERATURE ALLOWED FOR THE DEVICE. |
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