OAI

Assay, Enterovirus Nucleic Acid

Product code

OAI

Device name

Assay, Enterovirus Nucleic Acid

Device class

Class 2

21 CFR

21 CFR 866.3225

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).