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Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P030026 |
Supplement Number | S008 |
Date Received | 09/30/2005 |
Decision Date | 10/21/2005 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE THAT ADDRESSES THE ADDITION OF A CAUTION STATEMENT IN THE VITROS ANTI-HBC IGM REAGENT PACK INSTRUCTIONS FOR USE. |