Assay, Enterovirus Nucleic Acid
Device Code: 3522
Product Code(s):
OAI 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 Ent
Device Classification Information
| Device Type ID | 3522 |
| Device Name | Assay, Enterovirus Nucleic Acid |
| Physical State | N/A |
| Technical Method | Nucleic Acid Amplification Assay System, Self-contained Cartridge With Dedicated Instrument. |
| Target Area | Enterovirus (EV) RNA (enterovirus Genome 5 Prime Untranslated Region (UTR) Between Nucleotides 452 And 596) |
| Regulation Description | Enterovirus Nucleic Acid Assay. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3225 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3522 |
| Device | Assay, Enterovirus Nucleic Acid |
| Product Code | OAI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Enterovirus Nucleic Acid Assay. |
| CFR Regulation Number | 866.3225 [🔎] |
| Device Problems |
|---|
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 1 |
TPLC Last Update: 2019-04-02 20:31:39