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 MONOLOSA ANTI-HBC 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 | P060031 |
Supplement Number | S001 |
Date Received | 09/22/2008 |
Decision Date | 10/09/2008 |
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 ADDING A NEW FILLING MACHINE FOR USE IN THE MANUFACTURING OF THE POSITIVE AND NEGATIVE CONTROL VIALS AND THE CALIBRATOR VIAL IN THE KIT. |
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