Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.

Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P160044 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceAbbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.
Classification NameCytomegalovirus (cmv) Dna Quantitative Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantABBOTT MOLECULAR
Date Received2017-06-27
Decision Date2017-09-01
PMAP160044
SupplementS001
Product CodePAB
Advisory CommitteeMicrobiology
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018

Supplemental Filings

Supplement NumberDateSupplement Type
P160044Original Filing
S005 2022-12-20 30-day Notice
S004 2022-05-19 30-day Notice
S003 2021-02-05 30-day Notice
S002 2019-04-10 30-day Notice
S001 2017-06-27 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00884999047297 P160044 000
00884999045798 P160044 000
00884999045781 P160044 000
00884999045774 P160044 000

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