OSK

Anti-Glutamate Receptor (Type Nmda) Ifa

Product code

OSK

Device name

Anti-Glutamate Receptor (Type Nmda) Ifa

Device class

Class 2

21 CFR

21 CFR 866.5660

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).