PMA P140021S006
- Device
- ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S006
- Product code
- MZO
- Decision date
- 2016-03-16
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S006
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-03-16
- Decision code
- OK30
- Date received
- 2016-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of manufacturing activities for the purification and production of antibodies and proteins and for the lyophilization of raw materials and addition of new lyophilization equipment.