PMA P140021S015
- Device
- Elecsys ANti-HCV II (100/200 tests)
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S015
- Product code
- MZO
- Decision date
- 2018-11-06
- Classification
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Approval order statement
- Addition of a secondary manufacturer/supplier of a component raw material.
Current openFDA PMA Record#
- Device
- Elecsys ANti-HCV II (100/200 tests)
- Applicant
- Roche Diagnostics Operations, Inc.
- PMA number
- P140021
- Supplement
- S015
- Product code
- MZO
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Decision date
- 2018-11-06
- Decision code
- OK30
- Date received
- 2018-10-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a secondary manufacturer/supplier of a component raw material.