Voltage Gated Calcium Channel (Vgcc) Antibody Assay

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

Classification

FDA Product Code: PAF
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 semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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