DeviceClearance

Product code QDZ— Microbiology

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

Classification name
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Device class
Class 2
Regulation
21 CFR 866.3181
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.”

— U.S. Food and Drug Administration, device classification record for product code QDZ under 21 CFR 866.3181, via openFDA

Market context for product code QDZ

FDA has cleared 2 devices under product code QDZ between 2018 and 2022, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QDZ

Recent clearances under product code QDZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.