PMA P120012S017
- Device
- Abbott RealTime HCV Genotype II Assay
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S017
- Product code
- OBF
- Decision date
- 2018-06-21
- Classification
- Assay, Genotyping, Hepatitis C Virus
- Generic name
- Assay, genotyping, hepatitis c virus
- Approval order statement
- Modify the manufacturing and QC testing for a kit component and tighten an incoming reagent specification.
Current openFDA PMA Record#
- Device
- Abbott RealTime HCV Genotype II Assay
- Applicant
- Abbott Molecular
- PMA number
- P120012
- Supplement
- S017
- Product code
- OBF
- Generic name
- Assay, genotyping, hepatitis c virus
- Decision date
- 2018-06-21
- Decision code
- OK30
- Date received
- 2018-05-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the manufacturing and QC testing for a kit component and tighten an incoming reagent specification.