CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen
Clinical Chemistry · 21 CFR 862.1770 · Class 2
Overview
| Product Code | CDQ |
|---|---|
| Device Name | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Regulation | 21 CFR 862.1770 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 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 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | May 31, 2022 | SESE |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Sep 2, 2014 | SESE |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | Apr 21, 2011 | SESE |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | May 29, 2008 | SESE |
| K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | Horiba Abx | Oct 12, 2007 | SESE |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | Mar 27, 2006 | SESE |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | Jun 30, 2004 | SESE |
| K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | Precision Systems, Inc. | Mar 3, 2003 | SESE |
| K021385 | ATAC PAK BUN REAGENT | Elan Diagnostics | Jul 12, 2002 | SESE |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | Oct 15, 2001 | SESE |
| K012260 | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | Sep 19, 2001 | SESE |
| K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | Jul 17, 2001 | SESE |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | Sep 15, 2000 | SESE |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | May 24, 2000 | SESE |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | Apr 3, 2000 | SESE |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | Oct 18, 1999 | SESE |
| K992800 | 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 | BUN, MODEL BU 104-01 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| K982236 | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | Sigma Diagnostics, Inc. | Aug 5, 1998 | SESE |
| K981918 | 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
