|
Device | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & 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 | S001 |
Date Received | 04/11/2003 |
Decision Date | 04/30/2003 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITIONAL RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS. THE ADDITIONAL SUPPLIER WILL BE TECH GROUP IRELAND. |