Cytomegalovirus (cmv) Dna Quantitative Assay

FDA Premarket Approval P160044

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the abbott realtime cmv test is an in vitro polymerase chain reaction (pcr) assay for the quantitation of cytomegalovirus (cmv) dna in human edta plasma. The abbott realtime cmv test is intended for use as an aid in the management of hematopoietic stem cell transplant patients who are undergoing anti-cytomegalovirus therapy. In this population, serial dna measurement can be used to assess virological response to anti-cytomegalovirus therapy. The results from the realtime cmv test must be interpreted within the context of all relevant clinical and laboratory findings. The realtime cmv test is not intended as a screening test for the presence of cmv dna in blood or blood products.

Classification NameCytomegalovirus (cmv) Dna Quantitative Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
Date Received2016-10-04
Decision Date2017-05-18
Notice Date2017-06-01
Product CodePAB
Docket Number17M-3200
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

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


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

© 2023
This site is not affiliated with or endorsed by the FDA.