PMA P120012S012

Device: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S012
Product code: OBF
Decision date: 2016-04-12
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage.

Current openFDA PMA Record#

Device: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S012
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2016-04-12
Decision code: OK30
Date received: 2016-03-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage.