OAI · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3225
Classification
FDA Product Code
OAI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3225
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.