|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS |
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 | S002 |
Date Received | 07/07/2004 |
Decision Date | 07/16/2004 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REMOVAL OF THE IN-PROCESS TESTING OF THE FORMULATED CALIBRATOR BEFORE DISPENSING INTO VIALS SINCE THE TEST IS REPEATED DURING THE QUALITY CONTROL RELEASE OF THE ANTI-HCV REAGENT PACK AND CALIBRATORS. |