Product Code: CDQ FDA class 2 21 CFR 862.1770

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Clinical Chemistry

The Urease and Glutamic Dehydrogenase Urea Nitrogen Test is a clinical chemistry device that measures urea nitrogen by sequential enzymatic reactions involving urease (which converts urea to ammonia) and glutamic dehydrogenase (which consumes NADH proportionally to ammonia released), allowing photometric quantification, used in assessment of renal function. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDQ, regulated under 21 CFR 862.1770, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

117

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CDQ
Device Class: FDA class 2
Regulation Number: 862.1770
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 117 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203771	Urea Nitrogen2	May 31, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K140690	BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER	Sep 02, 2014	Substantially Equivalent	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K110675	EASYRA UREA NITROGEN AND CREATININE REAGENTS	Apr 21, 2011	Substantially Equivalent	MEDICA CORP.
K073295	UREA/BUN, SCAL, NORTROL, ABTROL	May 29, 2008	Substantially Equivalent	THERMO FISHER SCIENTIFIC OY
K070146	ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP	Oct 12, 2007	Substantially Equivalent	HORIBA ABX
K060120	TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM	Mar 27, 2006	Substantially Equivalent	TECO DIAGNOSTICS
K041051	RAICHEM BUN RATE REAGENT (LIQUID)	Jun 30, 2004	Substantially Equivalent	HEMAGEN DIAGNOSTICS, INC.
K024182	PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS	Mar 03, 2003	Substantially Equivalent	PRECISION SYSTEMS, INC.
K021385	ATAC PAK BUN REAGENT	Jul 12, 2002	Substantially Equivalent	ELAN DIAGNOSTICS
K012649	RAICHEM BUN RATE REAGENT	Oct 15, 2001	Substantially Equivalent	HEMAGEN DIAGNOSTICS, INC.
K012260	WIENER LAB. UREA UV CINETICA AA	Sep 19, 2001	Substantially Equivalent	WIENER LABORATORIES S.A.I.C.
K011596	UREA NITROGEN (BUN) LIQUID REAGENT	Jul 17, 2001	Substantially Equivalent	JAS DIAGNOSTIC, INC.
K002694	UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30	Sep 15, 2000	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K000958	ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS	May 24, 2000	Substantially Equivalent	ELAN HOLDINGS, INC.
K993925	WAKO L-TYPE UN TEST	Apr 03, 2000	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K993178	UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50	Oct 18, 1999	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K992800	SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P	Sep 28, 1999	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K990980	BUN, MODEL BU 104-01	May 25, 1999	Substantially Equivalent	A.P. TOTAL CARE, INC.
K982236	SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT	Aug 05, 1998	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K981918	UREA	Jul 28, 1998	Substantially Equivalent	ABBOTT LABORATORIES
K981123	UREA	Apr 24, 1998	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K981106	UREA NITROGEN (BUN) LIQUID REAGENT	Apr 16, 1998	Substantially Equivalent	TECO DIAGNOSTICS
K980057	CARESIDE BUN	Feb 05, 1998	Substantially Equivalent	EXIGENT DIAGNOSTICS, INC.
K974337	IL TEST UREA NITROGEN	Dec 17, 1997	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K973931	UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30	Nov 24, 1997	Substantially Equivalent	DIAGNOSTIC CHEMICALS LTD.
K971309	UREA	Aug 01, 1997	Substantially Equivalent	DERMA MEDIA LAB., INC.
K972671	BUN (LIQUID) REAGENT SET	Jul 20, 1997	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K971967	BUN	Jun 17, 1997	Substantially Equivalent	CAROLINA LIQUID CHEMISTRIES CORP.
K971477	UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)	May 27, 1997	Substantially Equivalent	TRACE AMERICA, INC.
K962418	UREA NITROGEN (BUN) LIQUI-UV	Dec 26, 1996	Substantially Equivalent	STANBIO LABORATORY
K960115	HICHEM BUN/UREA REAGENT KIT	Mar 29, 1996	Substantially Equivalent	ELAN PHARMA, INC.
K954000	ROCHE REAGENT FOR BUN	Oct 25, 1995	Substantially Equivalent	ROCHE DIAGNOSTIC SYSTEMS, INC.
K952742	BLOOD UREA NITROGEN REAGENT SYSTEM	Aug 11, 1995	Substantially Equivalent	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
K942984	BUN REAGENT	Mar 01, 1995	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K944250	UREA NITROGEN REAGENT	Feb 08, 1995	Substantially Equivalent	OLYMPUS CORP OF AMERICA
K934533	BUN-300/BUN-500 UREA NITROGEN REAGENT	Nov 26, 1993	Substantially Equivalent	HORIZON DIAGNOSTICS, INC.
K923506	UREA KIT	Sep 27, 1993	Substantially Equivalent	RANDOX LABORATORIES, LTD.
K932161	UREA NITROGEN TEST ITEM NUMBER 65408	Sep 08, 1993	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K931745	OLYMPUS REPLY UREA NITROGEN REAGENT	Aug 19, 1993	Substantially Equivalent	OLYMPUS CORP.
K925002	UREA NITROGEN TEST	Jan 04, 1993	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K924693	OLYMPUS BUN REAGENT	Nov 25, 1992	Substantially Equivalent	OLYMPUS CORP.
K923035	MILES URINE UREA NITROGEN METHOD	Sep 09, 1992	Substantially Equivalent	HERAEUS KULZER, INC.
K922597	OLYMPUS UREA NITROGEN (BUN) REAGENT	Jul 10, 1992	Substantially Equivalent	OLYMPUS CORP.
K914877	IL TEST(TM) UREA NITROGEN	Mar 11, 1992	Substantially Equivalent	INSTRUMENTATION LABORATORY CO.
K911248	SYNERMED UREA NITROGEN REAGENT KIT	Jun 03, 1991	Substantially Equivalent	SYNERMED, INC.
K905602	ECLIPSE ICA BUN	Jan 16, 1991	Substantially Equivalent	BIOTOPE, INC.
K903334	UREA NITROGEN TEST	Sep 07, 1990	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K902175	COULTER UREA NITROGEN REAGENT	Jun 12, 1990	Substantially Equivalent	COULTER CORP.
K901123	CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN	May 10, 1990	Substantially Equivalent	TECHNICON INSTRUMENTS CORP.
K900394	AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583	Apr 11, 1990	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K894836	DART UREA NITROGEN	Oct 30, 1989	Substantially Equivalent	COULTER ELECTRONICS, INC.
K895666	BUN (KINETIC)	Oct 27, 1989	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K894173	BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT	Sep 05, 1989	Substantially Equivalent	CATACHEM, INC.
K894378	UREA NITROGEN TEST (BUN) ITEM #65408	Aug 31, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K892331	ENZYMATIC UREA NITROGEN REAGENT SET	Jun 20, 1989	Substantially Equivalent	AMERICAN MONITOR CORP.
K891912	AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123	Jun 19, 1989	Substantially Equivalent	AMERICAN RESEARCH PRODUCTS CO.
K884987	UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022	Jan 13, 1989	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K881677	BUN (KINETIC)	Jun 07, 1988	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K881366	BIOTROL BUN ENZYMATIQUE UV H.P.	May 16, 1988	Substantially Equivalent	BIOTROL, USA, INC.
K880078	UREA NITROGEN (BUN)	Feb 11, 1988	Substantially Equivalent	TECH-NEAL SCIENTIFIC, INC.
K874477	EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010	Nov 23, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K873532	PARAMAX UREA NITROGEN REAGENT	Nov 23, 1987	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K873335	WAKO(TM) AUTOKIT UREA N	Oct 02, 1987	Substantially Equivalent	WAKO CHEMICALS, USA, INC.
K872484	MODIFIED ENZYMATIC BUN REAGENT	Aug 19, 1987	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K871547	ULTRA-VIOLET BUN REAGENT KIT (RATE)	Jun 22, 1987	Substantially Equivalent	BIOCHEMICAL TRADE, INC.
K870571	EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95	Mar 04, 1987	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K863925	UREA NITROGEN(BUN)	Nov 24, 1986	Substantially Equivalent	TECH-CO, INC.
K863260	BLOOD UREA NITROGEN(BUN) PROCEDURE	Sep 09, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K863196	BUN (RATE) REAGENT	Aug 26, 1986	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K862210	UREA NITROGEN (GLDH) REAGENT SET (UV)	Jul 01, 1986	Substantially Equivalent	STERLING DIAGNOSTICS, INC.
K861666	BLOOD UREA NITROGEN (BUN) PROCEDURE	Jul 01, 1986	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K860716	ENZYMATIC BUN REAGENT	Apr 24, 1986	Substantially Equivalent	TRACE SCIENTIFIC LTD.
K860135	EASY-TEST UREA (BUN) REAGENT	Feb 21, 1986	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K860109	ENZYMATIC UREA NITROGEN REAGENT SET	Feb 06, 1986	Substantially Equivalent	TECHNOSTICS INTL.
K853677	TDX REA BUN	Sep 16, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K853102	UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN	Aug 02, 1985	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K852292	DURAZYME UREA NITROGEN	Jul 08, 1985	Substantially Equivalent	AMERICAN MONITOR CORP.
K852131	BUN(ENDPOINT) REAGENT	Jun 10, 1985	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K851513	ULTRA-VIOLET BUN REAGENT KIT	May 20, 1985	Substantially Equivalent	BIO-ANALYTICS LABORATORIES, INC.
K850923	BUN (RATE) REAGENT	Mar 20, 1985	Substantially Equivalent	SIGMA DIAGNOSTICS, INC.
K844755	FOCUS UREA NITROGEN	Jan 08, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K844065	ENI BLOOD UREA NITROGEN REAGENT	Nov 27, 1984	Substantially Equivalent	ELECTRO-NUCLEONICS LABORATORIES, INC.
K843326	SYSTEMATE BUN HEM NO. 67221	Sep 14, 1984	Substantially Equivalent	EM DIAGNOSTIC SYSTEMS, INC.
K843057	UREA ASSAY KIT	Aug 27, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K842242	UREA ASSAY KIT	Jul 18, 1984	Substantially Equivalent	DIAGNOSTIC CHEMICALS, LTD. (USA)
K840064	UREA NITROGEN REAGENT SET	Jun 14, 1984	Substantially Equivalent	STERLING BIOCHEMICAL, INC.
K840785	PARAMAX UREA NITROGEN REAGENT	Apr 05, 1984	Substantially Equivalent	AMERICAN DADE
K833931	UREA NITROGEN-UV	Jan 13, 1984	Substantially Equivalent	SERAGEN DIAGNOSTICS, INC.
K832941	BUN LIQUID STABLE REAGENT SET	Oct 28, 1983	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K832749	EASYTOUCH BUN REAGENT SET	Oct 14, 1983	Substantially Equivalent	WORTHINGTON DIAGNOSTIC SYSTEMS
K831626	UREA NITROGEN-BUN-REAGENTS B6370-11A	Jul 07, 1983	Substantially Equivalent	AMERICAN SCIENTIFIC PRODUCTS
K831625	UREA NITROGEN-BUN-REAGENTS B6360-12	Jul 07, 1983	Substantially Equivalent	AMERICAN SCIENTIFIC PRODUCTS
K830241	ULTRA CHEM BUN-UV #65080-65081	Apr 05, 1983	Substantially Equivalent	EMD CHEMICALS INC.
K830555	AMRESCO UREA NITROGEN REAGENT SET	Mar 24, 1983	Substantially Equivalent	AMRESCO, INC.
K823300	BUN-UN CENTRIFICHUM 500, #65080/81	Jan 09, 1983	Substantially Equivalent	EMD CHEMICALS INC.
K823472	ULTRA CHEM BAN-UV #65080 & 65081	Dec 28, 1982	Substantially Equivalent	EMD CHEMICALS INC.
K823402	ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&	Dec 26, 1982	Substantially Equivalent	EMD CHEMICALS INC.
K821562	LANCER MSA BUN DIAG. KIT	Jun 11, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K812417	BLOOD UREA NITROGEN(BUN-UV)	Sep 09, 1981	Substantially Equivalent	REAGENTS APPLICATIONS, INC.
K812341	UREA NITROGEN (BUN)	Sep 01, 1981	Substantially Equivalent	POINTE SCIENTIFIC, INC.
K812290	FUN-UV SYSTEM PACK TEST	Aug 31, 1981	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K810794	A-GENT UREA NITROGEN	Apr 01, 1981	Substantially Equivalent	ABBOTT LABORATORIES
K802061	DATA-ZYME UREA NITROGEN REAGENT SET	Sep 26, 1980	Substantially Equivalent	DATA MEDICAL ASSOCIATES, INC.
K801116	COBAS REAGENT FOR BUN	Jun 17, 1980	Substantially Equivalent	ROCHE ANALYTICAL INSTRUMENTS, INC.
K800719	ENZYMATIC UREA NITROGEN REAGENT SET REVI	May 08, 1980	Substantially Equivalent	MACOMB CHEMICAL CO.
K800529	CENTRIFICHEM BUN	Mar 20, 1980	Substantially Equivalent	UNION CARBIDE CORP.
K800341	BUN REAGENT	Mar 12, 1980	Substantially Equivalent	GILFORD DIAGNOSTICS
K800128	CENTRIFICHEM BUN	Feb 13, 1980	Substantially Equivalent	UNION CARBIDE CORP.
K781782	BUN	Jan 10, 1979	Substantially Equivalent	GILFORD DIAGNOSTICS
K780943	BUN TEST UNI-UV BLOOD UREA NITROGEN TEST	Jul 27, 1978	Substantially Equivalent	SCLAVO, INC.
K780534	UREA NITROGEN (ENZYMATIC)	May 19, 1978	Substantially Equivalent	MACOMB CHEMICAL CO.
K780069	BUN REAGNET SET	Feb 14, 1978	Substantially Equivalent	MEDICAL ANALYSIS SYSTEMS, INC.
K771923	FASTCHEM BUN	Nov 11, 1977	Substantially Equivalent	BOEHRINGER MANNHEIM CORP.
K770654	UN, UV DELTA TEST ASSAY	Jun 24, 1977	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K770315	BUN, ENZYMATIC	Apr 05, 1977	Substantially Equivalent	ICN PHARMACEUTICALS, INC.
K761261	ENZYMATIC BUN (RATE) REAGENT KIT	Dec 29, 1976	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.
K760414	ENZYMATIC BUN REAGENT KIT	Nov 05, 1976	Substantially Equivalent	BECKMAN INSTRUMENTS, INC.

FEI Numbers

This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.

1000120319: 2 registrations

1000135102: 101 registrations

1000206808: 104 registrations

1000442352: 72 registrations

1181121: 182 registrations

1217183: 82 registrations

1220972: 44 registrations

1616487: 87 registrations

1827821: 149 registrations

1832216: 187 registrations

2050010: 124 registrations

2050012: 131 registrations

2221819: 65 registrations

2431530: 77 registrations

2432235: 462 registrations

2517506: 354 registrations

3000148879: 72 registrations

3000215862: 96 registrations

3001075266: 5 registrations

3002806559: 387 registrations

3002806560: 8 registrations

3002806809: 96 registrations

3003071743: 72 registrations

3003593973: 38 registrations

3003795116: 46 registrations

3004493545: 205 registrations

3005146313: 63 registrations

3005333358: 273 registrations

3006198300: 142 registrations

3006716639: 13 registrations

3007603826: 123 registrations

3007662974: 42 registrations

3009156722: 110 registrations

3010665957: 6 registrations

3010825766: 5 registrations

3011989923: 99 registrations

3012775350: 91 registrations

3013660430: 64 registrations

3015550354: 517 registrations

3016438761: 72 registrations

3037000637: 103 registrations

5864: 44 registrations