PMA P140021S001
- Device
- ELECSYS ANTI-HCV II
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S001
- Product code
- MZO
- Decision date
- 2015-11-24
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HCV II
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S001
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2015-11-24
- Decision code
- OK30
- Date received
- 2015-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A MODIFICATION TO AN IN-PROCESS TESTING PROCEDURE FOR THE SOLID PHASE COMPONENT USED IN THE ABOVE LISTED ELECSYS IMMUNOASSAYS.