Anti-Glutamate Receptor (Type Nmda) Ifa

OSK · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660

Classification

FDA Product Code: OSK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5660
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown