Anti-glutamate Receptor (type Nmda) Ifa
Device Code: 3090
Product Code(s):
OSK Definition: Intended For The Qualitative Determination Of Autoantibodies Against Glutamate Receptor (type NMDA) In Human Serum. Used As An Aid In The Diagnosis Of Anti-glutamate Receptor (type NMDA) Autoimmune Encephalitis In Conjunction With Other Laboratory An
Device Classification Information
| Device Type ID | 3090 |
| Device Name | Anti-glutamate Receptor (type Nmda) Ifa |
| Physical State | Solid, Liquid |
| Technical Method | Immunofluorescent Assay With Multiple Substrates |
| Target Area | Human Serum |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSK |
| 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 | 3090 |
| Device | Anti-glutamate Receptor (type Nmda) Ifa |
| Product Code | OSK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
TPLC Last Update: 2019-04-02 20:23:40