QCU · Class II · 21 CFR 866.3945

FDA Product Code QCU: Dengue Virus Antigen Assay

Qualitative Detection Of Dengue Virus Antigen In Human Serum Or Plasma Collected From Human Patients With Signs And Symptoms Consistent With Dengue Virus Infection

Leading manufacturers include InBios International, Inc..

Total

Cleared

84d

Avg days

2018

Since

FDA 510(k) Cleared Dengue Virus Antigen Assay Devices (Product Code QCU)

1 devices

1–1 of 1

Cleared Aug 27, 2018

DENV Detect NS1 ELISA

K181473

InBios International, Inc.

Microbiology · 84d

About Product Code QCU - Regulatory Context

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Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: Aug 27, 2018

Product Code Info

Code	QCU
Device class	Class II
CFR	21 CFR 866.3945
Panel	Microbiology

Verify on FDA.gov

View QCU classification on FDA.gov →