|
Device | Elecsys ANti-HCV II (100/200 tests) |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE ROAD P.O. BOX 50416 INDIANAPOLIS, IN 46250-0416 |
PMA Number | P140021 |
Supplement Number | S015 |
Date Received | 10/09/2018 |
Decision Date | 11/06/2018 |
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 Addition of a secondary manufacturer/supplier of a component raw material. |