Elisa, Antibody, West Nile Virus
Device Code: 3514
Product Code(s):
NOP Definition: The West Nile Virus ELISA Is Intended For The Detection Of IgG And IgM Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients.
Device Classification Information
| Device Type ID | 3514 |
| Device Name | Elisa, Antibody, West Nile Virus |
| Regulation Description | West Nile Virus Serological Reagents. |
| 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 | 866.3940 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOP |
| 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 | 3514 |
| Device | Elisa, Antibody, West Nile Virus |
| Product Code | NOP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | West Nile Virus Serological Reagents. |
| CFR Regulation Number | 866.3940 [🔎] |
TPLC Last Update: 2019-04-02 20:31:30