BLOOD UREA NITROGEN (BUN) REAGENT
Device Facts
| Record ID | K771312 |
|---|---|
| Device Name | BLOOD UREA NITROGEN (BUN) REAGENT |
| Applicant | Mallinckrodt Critical Care |
| Product Code | CDW · Clinical Chemistry |
| Decision Date | Aug 3, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
