Device Type ID | 3056 |
Device Name | Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) |
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 | NBO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |