OSK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Anti-Glutamate Receptor (Type Nmda) Ifa
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- FDA 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 and clinical findings.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM (K100017) | Euroimmun Us, Inc. | 2010-09-13 | + Add |
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