|
Device | Elecsys Anti-HCV Immunoassay |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P090009 |
Supplement Number | S017 |
Date Received | 10/11/2017 |
Decision Date | 12/20/2017 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for implementation of system software 06-04 on the cobas e 602 to address a software limitation |