|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND 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 | S020 |
Date Received | 06/14/2011 |
Decision Date | 09/15/2011 |
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 CHANGES TO IMPROVED METHOD OF ANTIFOAM 204 INCORPORATION INTO ANTI-HCV ASSAY REAGENT. |