|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P030024 |
Supplement Number | S003 |
Date Received | 04/08/2005 |
Decision Date | 05/05/2005 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN INCOMING RAW MATERIAL TEST. |