PMA P020011S016
- Device
- Aptima HCV RNA Qualitative Assay
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S016
- Product code
- MZP
- Decision date
- 2020-07-21
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Change the shipping container used to ship refrigerated product.
Current openFDA PMA Record#
- Device
- Aptima HCV RNA Qualitative Assay
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S016
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2020-07-21
- Decision code
- OK30
- Date received
- 2020-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the shipping container used to ship refrigerated product.