PMA P120012S011

Device: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S011
Product code: OBF
Decision date: 2016-04-20
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: Addition of a new purified water source and a new supplier of a raw material used in the production of bulk reagents.

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: S011
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2016-04-20
Decision code: OK30
Date received: 2016-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new purified water source and a new supplier of a raw material used in the production of bulk reagents.