COULTER DIRECT BILLRUBIN REAGENT
Device Facts
| Record ID | K905622 |
|---|---|
| Device Name | COULTER DIRECT BILLRUBIN REAGENT |
| Applicant | Coulter Electronics, Inc. |
| Product Code | CIG · Clinical Chemistry |
| Decision Date | Dec 26, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1110 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
