OAIClass II
Assay, Enterovirus Nucleic Acid
21 CFR 866.3225 / Microbiology
OAI is the FDA product code for Assay, Enterovirus Nucleic Acid, a class II device type, regulated under 21 CFR 866.3225. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OAI
- Device name
- Assay, Enterovirus Nucleic Acid
- 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.
- Regulation
- 21 CFR 866.3225
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code OAI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
Applicants with the most clearances
Product code OAI| Applicant | Clearances |
|---|---|
| Cepheid | 1 |
| bioMerieux, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.