PMA P120012S013

Device: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S013
Product code: OBF
Decision date: 2016-06-10
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: Relocation of manufacturing activities for the production of bulk reagents used for the Abbott mSample Preparation System.

Current openFDA PMA Record#

Device: ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S013
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2016-06-10
Decision code: OK30
Date received: 2016-04-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of manufacturing activities for the production of bulk reagents used for the Abbott mSample Preparation System.