DeviceClearance

Product code OZB— Microbiology

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

Classification name
Dengue Nucleic Acid Amplification Assay (Naat)
Device class
Class 2
Regulation
21 CFR 866.3946
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A qualitative in vitro diagnostic assay for the detection of dengue virus serotypes 1, 2, 3 or 4 in serum or plasma specimens collected from human patients with signs and symptoms consistent with dengue (mild or severe).”

— U.S. Food and Drug Administration, device classification record for product code OZB under 21 CFR 866.3946, via openFDA

Market context for product code OZB

FDA has cleared 1 device under product code OZB, all in 2012, 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 OZB

Recent clearances under product code OZB

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