DeviceClearance

Product code QCU— Microbiology

DENV Detect NS1 ELISA

Classification name
Dengue Virus Antigen Assay
Device class
Class 2
Regulation
21 CFR 866.3945
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code QCU under 21 CFR 866.3945, via openFDA

Market context for product code QCU

FDA has cleared 1 device under product code QCU, all in 2018, filed by 1 applicant company. 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.

Top applicants under product code QCU

Recent clearances under product code QCU

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