DeviceClearance

Product code OAI— Microbiology

NUCLISENS EASYQ ENTEROVIRUS SYSTEM

Classification name
Assay, Enterovirus Nucleic Acid
Device class
Class 2
Regulation
21 CFR 866.3225
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Consists of primers, probes, enzymes and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF) from individuals who have signs and symptoms consistent with meningitis or meningoencephalitis. The detection of enterovirus RNA, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of viral meningitis caused by enterovirus.”

— U.S. Food and Drug Administration, device classification record for product code OAI under 21 CFR 866.3225, via openFDA

Market context for product code OAI

FDA has cleared 2 devices under product code OAI between 2007 and 2008, filed by 2 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 OAI

Recent clearances under product code OAI

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