Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770) → CDL — Berthelot Indophenol, Urea Nitrogen

# CDL · Berthelot Indophenol, Urea Nitrogen

_Clinical Chemistry · 21 CFR 862.1770 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL

## Overview

- **Product Code:** CDL
- **Device Name:** Berthelot Indophenol, Urea Nitrogen
- **Regulation:** [21 CFR 862.1770](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1770)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K896845](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K896845.md) | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | Feb 16, 1990 | SESE |
| [K893128](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K893128.md) | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | Stanbio Laboratory | Jul 25, 1989 | SESE |
| [K871651](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K871651.md) | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | May 12, 1987 | SESE |
| [K864742](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K864742.md) | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | Jan 13, 1987 | SESE |
| [K863889](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K863889.md) | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | Nov 24, 1986 | SESE |
| [K863076](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K863076.md) | UREAFAST | J. D. Assoc. | Sep 9, 1986 | SESE |
| [K860154](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K860154.md) | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | Feb 6, 1986 | SESE |
| [K831414](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K831414.md) | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | Jun 16, 1983 | SESE |
| [K822237](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K822237.md) | UREA NITROGEN REAGENT SET (MOD. BERTHEL | Sterling Biochemical, Inc. | Aug 16, 1982 | SESE |
| [K810261](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K810261.md) | EUROCHIMA UREA NITROGEN | Volu Sol Medical Industries | Feb 10, 1981 | SESE |
| [K801727](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K801727.md) | DATA-ZYME UREA NITROGEN, COLORIMETRIC | Data Medical Associates, Inc. | Sep 9, 1980 | SESE |
| [K800902](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K800902.md) | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | Sclavo, Inc. | Jun 9, 1980 | SESE |
| [K792417](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K792417.md) | ELVI BLOOD UREA NITROGEN | Volu Sol Medical Industries | Dec 7, 1979 | SESE |
| [K781899](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K781899.md) | UREA NITROGEN TEST | Wako Intl., Inc. | Dec 20, 1978 | SESE |
| [K781306](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K781306.md) | UREA NITROGEN TEST KIT | Analytical & Research Chemicals, Inc. | Aug 31, 1978 | SESE |
| [K761152](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL/K761152.md) | S-UREA-N, IN VITRO DIAG FOR BUN | Advanced Biomedical Methods, Inc. | Dec 9, 1976 | SESE |

## Top Applicants

- Volu Sol Medical Industries — 2 clearances
- Advanced Biomedical Methods, Inc. — 1 clearance
- Analytical & Research Chemicals, Inc. — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
- Biochemical Trade, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDL)

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