- Device
- Elecsys Anti-HCV II
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S016
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2019-04-24
- Decision code
- APPR
- Date received
- 2018-10-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site for the cobas e 411 Analyzer located at Hitachi High-Technologies Corp., 1892-1, Oazategama, Omuta, Fukuoka, 836-0004 Japan