OAI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay, Enterovirus Nucleic Acid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3225
- Medical specialty
- Microbiology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NUCLISENS EASYQ ENTEROVIRUS SYSTEM (K063261) | bioMerieux, Inc. | 2008-06-23 |
| XPERT EV, MODEL GXEV-100N-10; GENEXPERT DX SYSTEM, MODELS P/N 900-0144, 900-0145, 900-0146, 900-0065 (DEN070004) | Cepheid | 2007-03-16 |
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Every clearance here is in the API, with alerts when new ones post.