Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking
Device Code: 3071
Product Code(s):
NST Definition: THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERF
Device Classification Information
| Device Type ID | 3071 |
| Device Name | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking |
| 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 | NST |
| 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 | 3071 |
| Device | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking |
| Product Code | NST |
| 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 20:23:24