PMA P120012S019
- Device
- Abbott RealTime HCV Genotype II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S019
- Product code
- OBF
- Decision date
- 2021-03-05
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- Addition of alternative testing location for a device component.
Current openFDA PMA Record#
- Device
- Abbott RealTime HCV Genotype II
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S019
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2021-03-05
- Decision code
- OK30
- Date received
- 2021-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative testing location for a device component.