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

Dengue Virus Antigen Assay

21 CFR 866.3945 / Microbiology
FDA source (opens on fda.gov)

QCU is the FDA product code for Dengue Virus Antigen Assay, a class II device type, regulated under 21 CFR 866.3945. FDA's definition for this code reads: "Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QCU
Device name
Dengue Virus Antigen Assay
FDA definition
Qualitative detection of Dengue virus antigen in human serum or plasma collected from human patients with signs and symptoms consistent with Dengue virus infection
Regulation
21 CFR 866.3945
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
1
Ingested recalls
0

Clearances, product code QCU

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

Applicants with the most clearances

Product code QCU
Applicants holding the most 510(k) clearances under product code QCU
ApplicantClearances
Inbios International, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code