PMA P100017S023
- Device
- Abbott RealTime HCV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P100017
- Supplement
- S023
- Product code
- MZP
- Decision date
- 2020-12-08
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- the implementation of an in-process QC test
Current openFDA PMA Record#
- Device
- Abbott RealTime HCV Assay
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P100017
- 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
- 2020-12-08
- Decision code
- OK30
- Date received
- 2020-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of an in-process QC test