DeviceClearance

Product code OZE— Microbiology

Accula Flu A/Flu B Test

Classification name
Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Total cleared
20
First cleared
Most recent

FDA classification definition

“An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.”

— U.S. Food and Drug Administration, device classification record for product code OZE under 21 CFR 866.3980, via openFDA

Market context for product code OZE

FDA has cleared 20 devices under product code OZE between 2012 and 2025, filed by 9 applicant companies. 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.

Clearances per year

Top applicants under product code OZE

Recent clearances under product code OZE

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