OAI — Assay, Enterovirus Nucleic Acid Class II
FDA product code OAI covers "Assay, Enterovirus Nucleic Acid", a Class II medical device regulated under 21 CFR 866.3225. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAI
- Device Class
- Class II
- Regulation Number
- 866.3225
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.