PMA P140021S010
- Device
- Elecsys Anti-HCV II, PreciControl Anti-HCV
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S010
- Product code
- MZO
- Decision date
- 2017-11-03
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 801 immunoassay analyzer.
Current openFDA PMA Record#
- Device
- Elecsys Anti-HCV II, PreciControl Anti-HCV
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S010
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2017-11-03
- Decision code
- APPR
- Date received
- 2017-07-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 801 immunoassay analyzer.