FDA product code OSK

Anti-Glutamate Receptor (Type Nmda) Ifa

Immunology·Class 2·21 CFR 866.5660
US regulatory classifications
US Product Code (FDA)
OSK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.5660
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Medical specialty
Immunology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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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About this record

Anti-Glutamate Receptor (Type Nmda) Ifa is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.