PMA P140021S007
- Device
- ELECSYS ANTI-HCV II IMMUNOASSAY.
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S007
- Product code
- MZO
- Decision date
- 2016-11-10
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Approval for the addition of K3-EDTA plasma as a specimen type for the Elecsys® Anti-HCV II Immunoassay.
Current openFDA PMA Record#
- Device
- ELECSYS ANTI-HCV II IMMUNOASSAY.
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S007
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2016-11-10
- Decision code
- APPR
- Date received
- 2016-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of K3-EDTA plasma as a specimen type for the Elecsys® Anti-HCV II Immunoassay.