PAF

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Voltage Gated Calcium Channel (Vgcc) Antibody Assay

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5660

Medical specialty

Immunology

Flags

Third-party review eligible

FDA 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.

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