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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device voltage gated calcium channel (vgcc) antibody assay
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.
Product CodePAF
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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