PMA P090007S006
- Device
- ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090007
- Supplement
- S006
- Product code
- MZO
- Decision date
- 2011-12-14
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- CHANGE TO SCALABLE LOT SIZES IN THE COMPONENT MANUFACTURING PROCESS OF ELECSYS® ANTI-HCV IMMUNOASSAY AND ELECSYS® PRECICONTROL ANTI-HCV AND A CHANGE IN THE LYOPHILISATION PROCESS.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HCV INMMUNOASSAY ON COBAS E 411
- Applicant
- Roche Diagnostics Corp.
- PMA number
- P090007
- Supplement
- S006
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2011-12-14
- Decision code
- OK30
- Date received
- 2011-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO SCALABLE LOT SIZES IN THE COMPONENT MANUFACTURING PROCESS OF ELECSYS® ANTI-HCV IMMUNOASSAY AND ELECSYS® PRECICONTROL ANTI-HCV AND A CHANGE IN THE LYOPHILISATION PROCESS.