PMA P160044S001

Device: Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.
Applicant: Abbott Molecular
PMA number: P160044
Supplement: S001
Product code: PAB
Decision date: 2017-09-01
Classification: Cytomegalovirus (cmv) Dna Quantitative Assay
Generic name: Cytomegalovirus (cmv) dna quantitative assay
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 CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.
Applicant: Abbott Molecular
PMA number: P160044
Supplement: S001
Product code: PAB
Generic name: Cytomegalovirus (cmv) dna quantitative assay
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.