OSK · Class II · 21 CFR 866.5660

FDA Product Code OSK: Anti-glutamate Receptor (type Nmda) Ifa

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.

Leading manufacturers include Euroimmun Us, Inc..

1
Total
1
Cleared
252d
Avg days
2010
Since

FDA 510(k) Cleared Anti-glutamate Receptor (type Nmda) Ifa Devices (Product Code OSK)

1 devices
1–1 of 1
Cleared Sep 13, 2010
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
K100017
Euroimmun Us, Inc.
Immunology · 252d

About Product Code OSK - Regulatory Context