PAFClass II
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
21 CFR 866.5660 / Immunology
PAF is the FDA product code for Voltage Gated Calcium Channel (Vgcc) Antibody Assay, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PAF
- Device name
- Voltage Gated Calcium Channel (Vgcc) Antibody Assay
- 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.
- Regulation
- 21 CFR 866.5660
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PAF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 1 |
Applicants with the most clearances
Product code PAF| Applicant | Clearances |
|---|---|
| Kronus Market Development Associates, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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