|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS |
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 | P000014 |
Supplement Number | S002 |
Date Received | 03/12/2001 |
Decision Date | 08/29/2001 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE THE TEST RELEASE LIMITS APPLIED TO THE OUTPUT OF THAT MODEL FOR THE VITROS ANTI-HBS ASSAY. |