DeviceClearance

Product code OSU— Microbiology

DENV DETECT IGM CAPTURE ELISA

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

FDA classification definition

“Dengue virus serological reagents are devices that consist of antigens and antisera for the detection of anti-dengue antibodies, individuals that have signs and symptoms consistent with dengue. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus. The device is intended for use in the presumptive diagnosis of patients in conjunction with other clinical and laboratory findings.”

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

Market context for product code OSU

FDA has cleared 1 device under product code OSU, all in 2011, 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 OSU

Recent clearances under product code OSU

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