Device Type ID | 2946 |
Device Name | Albumin, Fitc, Antigen, Antiserum, Control |
Regulation Description | Albumin 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) Exempt |
CFR Regulation Number | 866.5040 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DDZ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |