PMA P120012S010

Device: ABBOTT REALTIME HCV GENOTYPE II
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S010
Product code: OBF
Decision date: 2016-03-07
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.

Current openFDA PMA Record#

Device: ABBOTT REALTIME HCV GENOTYPE II
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S010
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2016-03-07
Decision code: APPR
Date received: 2015-12-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process.