PMA P140021S013
- Device
- Elecsys Anti-HCV II
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S013
- Product code
- MZO
- Decision date
- 2018-04-20
- 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 02-07) to the cobas e 411 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HCV II
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S013
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2018-04-20
- Decision code
- APPR
- Date received
- 2018-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update (version 02-07) to the cobas e 411 immunoassay analyzer.