PMA P020011S009
- Device
- APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S009
- Product code
- MZP
- Decision date
- 2016-09-19
- Classification
- Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Approval of a new supplier for a critical raw material.
Current openFDA PMA Record#
- Device
- APTIMA HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S009
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2016-09-19
- Decision code
- APPR
- Date received
- 2015-09-04
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of a new supplier for a critical raw material.