PAF · Class II · 21 CFR 866.5660

FDA Product Code PAF: Voltage Gated Calcium Channel (vgcc) Antibody Assay

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.

1
Total
1
Cleared
324d
Avg days
2012
Since

FDA 510(k) Cleared Voltage Gated Calcium Channel (vgcc) Antibody Assay Devices (Product Code PAF)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code PAF - Regulatory Context