|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 |
PMA Number | P010021 |
Supplement Number | S019 |
Date Received | 03/24/2011 |
Decision Date | 08/02/2011 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
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 FOR THE REPLACEMENT OF A RAW MATERIAL, FOETAL CALF SERUM, WITH BOVINE SERUM ALBUMIN IN THE FORMULATION OF THE VITROS ANTI-HCV CONJUGATE REAGENT. |