510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QDZClass II

Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection

21 CFR 866.3181 / Microbiology
FDA source (opens on fda.gov)

QDZ is the FDA product code for Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection, a class II device type, regulated under 21 CFR 866.3181. FDA's definition for this code reads: "The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDZ
Device name
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
FDA definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Regulation
21 CFR 866.3181
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QDZ

By decision year
2 clearances under product code QDZ with a decision year between 2018 and 2022, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDZ by decision year
YearClearances
20181
20221

Applicants with the most clearances

Product code QDZ
Applicants holding the most 510(k) clearances under product code QDZ
ApplicantClearances
DiaSorin Molecular LLC1
Meridian Bioscience Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code