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U.S. Department of Health and Human Services

Product Classification

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Device anti-glutamate receptor (type nmda) ifa
Regulation Description Multiple autoantibodies immunological test system.
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.
Physical State Solid, liquid
Technical Method Immunofluorescent assay with multiple substrates
Target Area Human serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOSK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons