Voltage Gated Calcium Channel (vgcc) Antibody Assay
Device Code: 3095
Product Code(s):
PAF 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 Clini
Device Classification Information
| Device Type ID | 3095 |
| Device Name | Voltage Gated Calcium Channel (vgcc) Antibody Assay |
| Physical State | VGCC Labeled With 125 Iodine-w-Conotoxin MVIIC (lyophilized) In 12x75 Polysterene Test Tubes; Positive And Negative Controls; Total Binding & Non-Specific Binding Tubes; Anti-human IgG; Buffer; Wash Solution |
| Technical Method | Radioimmunoassay (RIA) Assay Using Radioactive Labeled Material |
| Target Area | Serum Samples |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5660 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3095 |
| Device | Voltage Gated Calcium Channel (vgcc) Antibody Assay |
| Product Code | PAF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiple Autoantibodies Immunological Test System. |
| CFR Regulation Number | 866.5660 [🔎] |
TPLC Last Update: 2019-04-02 20:23:44