| Device Type ID | 450 |
| Device Name | Azo-dyes, Colorimetric, Bilirubin & Its Conjugates (urinary, Non-quant.) |
| Regulation Description | Urinary Bilirubin And Its Conjugates (nonquantitative) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1115 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |