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Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Voltage Gated Calcium Channel (Vgcc) Antibody Assay is a medical device type in the Immunology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
Immunology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PAF

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Class 2

21 CFR 866.5660

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Immunology

Device Characteristics

No

No

No

Eligible

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.