PMA P090008S020
- Device
- Elecsys Anti-HCV Immunoassay
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090008
- Supplement
- S020
- Product code
- MZO
- Decision date
- 2018-06-13
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series
Current openFDA PMA Record#
- Device
- Elecsys Anti-HCV Immunoassay
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090008
- Supplement
- S020
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2018-06-13
- Decision code
- APPR
- Date received
- 2018-04-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update (version 06-05) for the cobas 8000 Modular Analyzer Series