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) → CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen # CDQ · Urease And Glutamic Dehydrogenase, 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/CDQ ## Overview - **Product Code:** CDQ - **Device Name:** Urease And Glutamic Dehydrogenase, 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 (20 of 117) Showing 20 most recent of 117 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K203771](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K203771.md) | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | May 31, 2022 | SESE | | [K140690](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K140690.md) | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Sep 2, 2014 | SESE | | [K110675](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K110675.md) | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | Apr 21, 2011 | SESE | | [K073295](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K073295.md) | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | May 29, 2008 | SESE | | [K070146](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K070146.md) | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Horiba Abx | Oct 12, 2007 | SESE | | [K060120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K060120.md) | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | Mar 27, 2006 | SESE | | [K041051](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K041051.md) | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | Jun 30, 2004 | SESE | | [K024182](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K024182.md) | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | Precision Systems, Inc. | Mar 3, 2003 | SESE | | [K021385](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K021385.md) | ATAC PAK BUN REAGENT | Elan Diagnostics | Jul 12, 2002 | SESE | | [K012649](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K012649.md) | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | Oct 15, 2001 | SESE | | [K012260](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K012260.md) | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | Sep 19, 2001 | SESE | | [K011596](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K011596.md) | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | Jul 17, 2001 | SESE | | [K002694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K002694.md) | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | Sep 15, 2000 | SESE | | [K000958](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K000958.md) | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | May 24, 2000 | SESE | | [K993925](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K993925.md) | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | Apr 3, 2000 | SESE | | [K993178](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K993178.md) | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | Oct 18, 1999 | SESE | | [K992800](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K992800.md) | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P | Sigma Diagnostics, Inc. | Sep 28, 1999 | SESE | | [K990980](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K990980.md) | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | May 25, 1999 | SESE | | [K982236](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K982236.md) | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | Sigma Diagnostics, Inc. | Aug 5, 1998 | SESE | | [K981918](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K981918.md) | UREA | Abbott Laboratories | Jul 28, 1998 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 9 clearances - Sigma Diagnostics, Inc. — 5 clearances - Abbott Laboratories — 4 clearances - Boehringer Mannheim Corp. — 4 clearances - Emd Chemicals, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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