|
Device | VITROS IMMUNODIAGNOSTIC 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 | S005 |
Date Received | 02/02/2005 |
Decision Date | 02/11/2005 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF RAW MATERIAL SPECIFICATION. |