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. |
|
Device | BIO-RAD MONOLISA ANTI-HBS EIA & 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 | S001 |
Date Received | 07/01/2008 |
Decision Date | 07/17/2008 |
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 ADDITION OF A NEW FILLING MACHINE FOR USE IN THE MANUFACTURE OF FILLED POSITIVE AND NEGATIVE CONTROL VIALS AND CALIBRATOR VIALS. |
|
|