Urease And Glutamic Dehydrogenase, Urea Nitrogen

FDA product code CDQ · 116 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1770
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-05 – 2022-05-31

CDQ 2022-05-31

Urea Nitrogen2

Applicant Abbott Ireland Diagnostics Division

K number K203771

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CDQ 2011-04-21

EASYRA UREA NITROGEN AND CREATININE REAGENTS

Applicant Medica Corp.

K number K110675

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CDQ 2008-05-29

UREA/BUN, SCAL, NORTROL, ABTROL

Applicant Thermofisher Scientific OY

K number K073295

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CDQ 2007-10-12

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

Applicant Horiba Abx

K number K070146

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CDQ 2006-03-27

TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM

Applicant Teco Diagnostics

K number K060120

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CDQ 2004-06-30

RAICHEM BUN RATE REAGENT (LIQUID)

Applicant Hemagen Diagnostics, Inc.

K number K041051

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CDQ 2003-03-03

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS

Applicant Precision Systems, Inc.

K number K024182

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CDQ 2002-07-12

ATAC PAK BUN REAGENT

Applicant Elan Diagnostics

K number K021385

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CDQ 2001-10-15

RAICHEM BUN RATE REAGENT

Applicant Hemagen Diagnostics, Inc.

K number K012649

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CDQ 2001-09-19

WIENER LAB. UREA UV CINETICA AA

Applicant Wiener Laboratories Saic

K number K012260

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CDQ 2001-07-17

UREA NITROGEN (BUN) LIQUID REAGENT

Applicant Jas Diagnostic, Inc.

K number K011596

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CDQ 2000-09-15

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30

Applicant Diagnostic Chemicals , Ltd.

K number K002694

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CDQ 2000-05-24

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

Applicant Elan Holdings, Inc.

K number K000958

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CDQ 2000-04-03

WAKO L-TYPE UN TEST

Applicant Wako Chemicals USA, Inc.

K number K993925

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CDQ 1999-10-18

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50

Applicant Diagnostic Chemicals , Ltd.

K number K993178

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CDQ 1999-09-28

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

Applicant Sigma Diagnostics, Inc.

K number K992800

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CDQ 1999-05-25

BUN, MODEL BU 104-01

Applicant A.P. Total Care, Inc.

K number K990980

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CDQ 1998-08-05

SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT

Applicant Sigma Diagnostics, Inc.

K number K982236

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CDQ 1998-07-28

UREA

Applicant Abbott Laboratories

K number K981918

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CDQ 1998-04-24

UREA

Applicant Trace Scientific , Ltd.

K number K981123

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CDQ 1998-04-16

UREA NITROGEN (BUN) LIQUID REAGENT

Applicant Teco Diagnostics

K number K981106

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CDQ 1998-02-05

CARESIDE BUN

Applicant Exigent Diagnostics, Inc.

K number K980057

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CDQ 1997-12-17

IL TEST UREA NITROGEN

Applicant Instrumentation Laboratory CO

K number K974337

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CDQ 1997-11-24

UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30

Applicant Diagnostic Chemicals , Ltd.

K number K973931

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CDQ 1997-08-01

UREA

Applicant Derma Media Lab., Inc.

K number K971309

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CDQ 1997-07-20

BUN (LIQUID) REAGENT SET

Applicant Pointe Scientific, Inc.,

K number K972671

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CDQ 1997-06-17

BUN

Applicant Carolina Liquid Chemistries Corp.

K number K971967

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CDQ 1997-05-27

UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

Applicant Trace America, Inc.

K number K971477

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CDQ 1996-12-26

UREA NITROGEN (BUN) LIQUI-UV

Applicant Stanbio Laboratory

K number K962418

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CDQ 1996-03-29

HICHEM BUN/UREA REAGENT KIT

Applicant Elan Pharma, Inc.

K number K960115

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CDQ 1995-10-25

ROCHE REAGENT FOR BUN

Applicant Roche Diagnostic Systems, Inc.

K number K954000

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CDQ 1995-08-11

BLOOD UREA NITROGEN REAGENT SYSTEM

Applicant Medical Diagnostic Technologies, Inc.

K number K952742

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CDQ 1995-03-01

BUN REAGENT

Applicant American Research Products Co.

K number K942984

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CDQ 1995-02-08

UREA NITROGEN REAGENT

Applicant Olympus Corp of America

K number K944250

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CDQ 1993-11-26

BUN-300/BUN-500 UREA NITROGEN REAGENT

Applicant Horizon Diagnostics, Inc.

K number K934533

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CDQ 1993-09-27

UREA KIT

Applicant Randox Laboratories, Ltd.

K number K923506

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CDQ 1993-09-08

UREA NITROGEN TEST ITEM NUMBER 65408

Applicant Em Diagnostic Systems, Inc.

K number K932161

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CDQ 1993-08-19

OLYMPUS REPLY UREA NITROGEN REAGENT

Applicant Olympus Corp.

K number K931745

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CDQ 1993-01-04

UREA NITROGEN TEST

Applicant Em Diagnostic Systems, Inc.

K number K925002

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CDQ 1992-11-25

OLYMPUS BUN REAGENT

Applicant Olympus Corp.

K number K924693

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CDQ 1992-09-09

MILES URINE UREA NITROGEN METHOD

Applicant Heraeus Kulzer, Inc.

K number K923035

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CDQ 1992-07-10

OLYMPUS UREA NITROGEN (BUN) REAGENT

Applicant Olympus Corp.

K number K922597

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CDQ 1992-03-11

IL TEST(TM) UREA NITROGEN

Applicant Instrumentation Laboratory CO

K number K914877

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CDQ 1991-06-03

SYNERMED UREA NITROGEN REAGENT KIT

Applicant Synermed, Inc.

K number K911248

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CDQ 1991-01-16

ECLIPSE ICA BUN

Applicant Biotope, Inc.

K number K905602

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CDQ 1990-09-07

UREA NITROGEN TEST

Applicant Em Diagnostic Systems, Inc.

K number K903334

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CDQ 1990-06-12

COULTER UREA NITROGEN REAGENT

Applicant Coulter Corp.

K number K902175

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CDQ 1990-05-10

CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN

Applicant Technicon Instruments Corp.

K number K901123

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CDQ 1990-04-11

AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583

Applicant American Research Products Co.

K number K900394

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CDQ 1989-10-30

DART UREA NITROGEN

Applicant Coulter Electronics, Inc.

K number K894836

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CDQ 1989-10-27

BUN (KINETIC)

Applicant Boehringer Mannheim Corp.

K number K895666

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CDQ 1989-09-05

BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT

Applicant Catachem, Inc.

K number K894173

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CDQ 1989-08-31

UREA NITROGEN TEST (BUN) ITEM #65408

Applicant Em Diagnostic Systems, Inc.

K number K894378

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CDQ 1989-06-20

ENZYMATIC UREA NITROGEN REAGENT SET

Applicant American Monitor Corp.

K number K892331

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CDQ 1989-06-19

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123

Applicant American Research Products Co.

K number K891912

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CDQ 1989-01-13

UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022

Applicant Em Diagnostic Systems, Inc.

K number K884987

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CDQ 1988-06-07

BUN (KINETIC)

Applicant Boehringer Mannheim Corp.

K number K881677

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CDQ 1988-05-16

BIOTROL BUN ENZYMATIQUE UV H.P.

Applicant Biotrol, USA, Inc.

K number K881366

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CDQ 1988-02-11

UREA NITROGEN (BUN)

Applicant Tech-Neal Scientific, Inc.

K number K880078

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CDQ 1987-11-23

EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010

Applicant Em Diagnostic Systems, Inc.

K number K874477

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CDQ 1987-11-23

PARAMAX UREA NITROGEN REAGENT

Applicant Baxter Healthcare Corp

K number K873532

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CDQ 1987-10-02

WAKO(TM) AUTOKIT UREA N

Applicant Wako Chemicals USA, Inc.

K number K873335

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CDQ 1987-08-19

MODIFIED ENZYMATIC BUN REAGENT

Applicant Trace Scientific , Ltd.

K number K872484

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CDQ 1987-06-22

ULTRA-VIOLET BUN REAGENT KIT (RATE)

Applicant Biochemical Trade, Inc.

K number K871547

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CDQ 1987-03-04

EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95

Applicant Em Diagnostic Systems, Inc.

K number K870571

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CDQ 1986-11-24

UREA NITROGEN(BUN)

Applicant Tech-Co, Inc.

K number K863925

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CDQ 1986-09-09

BLOOD UREA NITROGEN(BUN) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863260

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CDQ 1986-08-26

BUN (RATE) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K863196

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CDQ 1986-07-01

UREA NITROGEN (GLDH) REAGENT SET (UV)

Applicant Sterling Diagnostics, Inc.

K number K862210

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CDQ 1986-07-01

BLOOD UREA NITROGEN (BUN) PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861666

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CDQ 1986-04-24

ENZYMATIC BUN REAGENT

Applicant Trace Scientific , Ltd.

K number K860716

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CDQ 1986-02-21

EASY-TEST UREA (BUN) REAGENT

Applicant Em Diagnostic Systems, Inc.

K number K860135

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CDQ 1986-02-06

ENZYMATIC UREA NITROGEN REAGENT SET

Applicant Technostics Intl.

K number K860109

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CDQ 1985-09-16

TDX REA BUN

Applicant Abbott Laboratories

K number K853677

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CDQ 1985-08-02

UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K853102

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CDQ 1985-07-08

DURAZYME UREA NITROGEN

Applicant American Monitor Corp.

K number K852292

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CDQ 1985-06-10

BUN(ENDPOINT) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K852131

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CDQ 1985-05-20

ULTRA-VIOLET BUN REAGENT KIT

Applicant Bio-Analytics Laboratories, Inc.

K number K851513

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CDQ 1985-03-20

BUN (RATE) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K850923

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CDQ 1985-01-08

FOCUS UREA NITROGEN

Applicant Abbott Laboratories

K number K844755

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CDQ 1984-11-27

ENI BLOOD UREA NITROGEN REAGENT

Applicant Electro-Nucleonics Laboratories, Inc.

K number K844065

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CDQ 1984-09-14

SYSTEMATE BUN HEM NO. 67221

Applicant Em Diagnostic Systems, Inc.

K number K843326

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CDQ 1984-08-27

UREA ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K843057

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CDQ 1984-07-18

UREA ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K842242

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CDQ 1984-06-14

UREA NITROGEN REAGENT SET

Applicant Sterling Biochemical, Inc.

K number K840064

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CDQ 1984-04-05

PARAMAX UREA NITROGEN REAGENT

Applicant American Dade

K number K840785

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CDQ 1984-01-13

UREA NITROGEN-UV

Applicant Seragen Diagnostics, Inc.

K number K833931

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CDQ 1983-10-28

BUN LIQUID STABLE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K832941

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CDQ 1983-10-14

EASYTOUCH BUN REAGENT SET

Applicant Worthington Diagnostic Systems

K number K832749

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CDQ 1983-07-07

UREA NITROGEN-BUN-REAGENTS B6370-11A

Applicant American Scientific Products

K number K831626

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CDQ 1983-07-07

UREA NITROGEN-BUN-REAGENTS B6360-12

Applicant American Scientific Products

K number K831625

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CDQ 1983-04-05

ULTRA CHEM BUN-UV #65080-65081

Applicant Emd Chemicals, Inc.

K number K830241

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CDQ 1983-03-24

AMRESCO UREA NITROGEN REAGENT SET

Applicant Amresco, Inc.

K number K830555

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CDQ 1983-01-09

BUN-UN CENTRIFICHUM 500, #65080/81

Applicant Emd Chemicals, Inc.

K number K823300

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CDQ 1982-12-28

ULTRA CHEM BAN-UV #65080 & 65081

Applicant Emd Chemicals, Inc.

K number K823472

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CDQ 1982-12-26

ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080&

Applicant Emd Chemicals, Inc.

K number K823402

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CDQ 1982-06-11

LANCER MSA BUN DIAG. KIT

Applicant Sherwood Medical Co.

K number K821562

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CDQ 1981-09-09

BLOOD UREA NITROGEN(BUN-UV)

Applicant Reagents Applications, Inc.

K number K812417

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CDQ 1981-09-01

UREA NITROGEN (BUN)

Applicant Pointe Scientific, Inc.,

K number K812341

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CDQ 1981-08-31

FUN-UV SYSTEM PACK TEST

Applicant Boehringer Mannheim Corp.

K number K812290

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