PMA P000010S023
- Device
- AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S023
- Product code
- MZP
- Decision date
- 2011-08-09
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- CHANGE TO THE MANUFACTURING BATCH SIZE FOR THE BULK SPECIMEN DILUENT, WHICH IS A COMPONENT OF THE DEVICE.
Current openFDA PMA Record
- Device
- AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S023
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2011-08-09
- Decision code
- OK30
- Date received
- 2011-07-15
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE MANUFACTURING BATCH SIZE FOR THE BULK SPECIMEN DILUENT, WHICH IS A COMPONENT OF THE DEVICE.