PMA P120012S016

Device: Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S016
Product code: OBF
Decision date: 2017-09-01
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.

Current openFDA PMA Record#

Device: Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S016
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2017-09-01
Decision code: APPR
Date received: 2017-06-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.