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) → CDN — Urease, Photometric, Urea Nitrogen

# CDN · Urease, Photometric, 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/CDN

## Overview

- **Product Code:** CDN
- **Device Name:** Urease, Photometric, 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 |
| --- | --- | --- | --- | --- |
| [K190326](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K190326.md) | VITROS XT Chemistry Products UREA-CREA Slides | Ortho-Clinical Diagnostics, Inc. | Mar 14, 2019 | SESE |
| [K132462](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K132462.md) | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Hitachi Chemical Diagnostics, Inc. | Oct 28, 2013 | SESE |
| [K123322](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K123322.md) | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | Alfa Wassermann Diagnostics Technologies, LLC | May 21, 2013 | SESE |
| [K113389](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K113389.md) | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | Aug 10, 2012 | SESE |
| [K103615](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K103615.md) | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Alfa Wassermann Diagnostic Technologies, Inc. | Sep 8, 2011 | SESE |
| [K001885](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K001885.md) | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | Jul 20, 2000 | SESE |
| [K972012](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K972012.md) | CHOLESTECH BUN/CREATININE TEST SYSTEM | Cholestech Corp. | Jul 24, 1997 | SESE |
| [K961196](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K961196.md) | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | Johnson & Johnson Clinical Diagnostics, Inc. | May 15, 1996 | SESE |
| [K943042](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K943042.md) | BUN QVET | Prisma Systems | Dec 29, 1994 | SESE |
| [K922969](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K922969.md) | KING DIAGNOSTICS UREA NITROGEN REAGENT | King Diagnostics, Inc. | Oct 13, 1992 | SESE |
| [K914903](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K914903.md) | QUICKSTART UREA NITROGEN | Em Diagnostic Systems, Inc. | Dec 31, 1991 | SESE |
| [K822154](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K822154.md) | UREA NITROGEN (ENZYMATIC) DETERMINATION | The Dow Chemical Co. | Aug 5, 1982 | SESE |
| [K802518](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K802518.md) | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | Nov 12, 1980 | SESE |
| [K792328](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K792328.md) | STATTEK BUN | Boehringer Mannheim Corp. | Dec 18, 1979 | SESE |
| [K781253](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K781253.md) | BUN (UREASE) REAGENT | Coulter Electronics, Inc. | Aug 21, 1978 | SESE |
| [K771442](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDN/K771442.md) | MULTISTAT III UREA NITROGEN TEST | Instrumentation Laboratory CO | Aug 22, 1977 | SESE |

## Top Applicants

- Alfa Wassermann Diagnostic Technologies, Inc. — 2 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
- Alfa Wassermann Diagnostics Technologies, LLC — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Cholestech Corp. — 1 clearance

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

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