Assay, Enterovirus Nucleic Acid
The Assay, Enterovirus Nucleic Acid (product code OAI) is a molecular diagnostic assay comprising primers, probes, enzymes, and controls for the amplification and detection of enterovirus RNA in cerebrospinal fluid (CSF), used to aid in the clinical laboratory diagnosis of viral meningitis and meningoencephalitis caused by enteroviruses. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.3225 within the Microbiology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAI
- Device Class
- FDA class 2
- Regulation Number
- 866.3225
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.