Product code CIX

Device name: Bromcresol Green Dye-Binding, Albumin
Medical specialty: Clinical Chemistry
Device class: 2
Regulation number: 862.1035
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K251157	Core Metabolic	Truvian Health	2026-01-09
K203248	Albumin BCG2	Abbott Ireland Diagnostics Division	2021-11-23
K200898	Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin	Medicon Hellas S.A	2021-09-21
K191316	VITROS XT Chemistry Products ALB-TP Slides	Ortho-Clinical Diagnostics, Inc.	2019-06-07
K170901	ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400	Biosystems S.A.	2018-04-13
K131488	ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT	Alfa Wassermann Diagnostics Technologies, LLC	2013-08-19
K113374	ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT	Alfa Wassermann Diagnostic Technologies, Inc.	2012-07-13
K110818	POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS	Polymedco, Inc.	2011-09-08
K110830	ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH	Elitechgroup	2011-06-21
K101088	EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT	Medica Corp.	2011-04-04
K080874	EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT	Medica Corp.	2009-02-20
K072143	S40 CLINICAL ANALYZER, S TEST ALB	Alfa Wassermann Diagnostic Technologies, Inc.	2008-07-14
K060434	ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL	Horiba Abx	2007-06-05
K033009	ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2	Roche Diagnostics Corp.	2003-10-16
K030006	ATAC PAK ALBUMIN REAGENT	Elan Diagnostics	2003-03-07
K023875	VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4	Ortho-Clinical Diagnostics, Inc.	2002-12-10
K022072	PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS	Precision Systems, Inc.	2002-08-23
K012329	WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300	Wiener Laboratories Saic	2001-09-21
K011720	OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2001-06-25
K010877	CHEMWELL, MODEL 2900	Awareness Technology, Inc.	2001-05-23
K003327	ALBUMIN	Jas Diagnostics, Inc.	2000-12-05
K992399	ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM	Bayer Corp.	1999-09-15
K991576	ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM	Bayer Corp.	1999-06-30
K984494	RANDOX ALBUMIN	Randox Laboratories, Ltd.	1999-03-23
K981758	ALBG	Abbott Laboratories	1998-06-12
K980041	CARESIDE ALBUMIN	Exigent Diagnostics, Inc.	1998-02-04
K971445	ALB OR ALBUMIN	Carolina Liquid Chemistries Corp.	1997-05-02
K955781	ALBUMIN	Derma Media Lab., Inc.	1996-03-13
K952488	TRACE COBAS MIRA RANGE	Trace Scientific , Ltd.	1995-10-13
K946355	DMA ALBUMIN PROCEDURE	Data Medical Associates, Inc.	1995-03-01

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00630414654140	Atellica CH Alb	Siemens Healthcare Diagnostics Inc.	2026-03-18
10673486013726	Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TECO DIAGNOSTICS	2025-05-28
10673486013894	Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TECO DIAGNOSTICS	2025-05-28
10673486013962	Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TECO DIAGNOSTICS	2025-05-28
10673486013580	Teco Diagnostics TC Matrix Clinical Chemistry Analyzer	TECO DIAGNOSTICS	2025-05-28
00380740155889	ARCHITECT	ABBOTT IRELAND	2024-08-15
00380740155872	ARCHITECT	ABBOTT IRELAND	2024-08-15
00380740155353	Alinity	ABBOTT IRELAND	2024-08-15
00380740155346	Alinity	ABBOTT IRELAND	2024-08-15
00850053916007	IDG/Sanzay	IDG/SANZAY Corporation	2023-12-18
10673486001013	Albumin Reagent Set	TECO DIAGNOSTICS	2023-07-07
10673486001020	Albumin -BCG method TC-Matrix	TECO DIAGNOSTICS	2023-07-07
00811727016003	Pointe Albumin Reagent	HORIBA INSTRUMENTS INCORPORATED	2021-01-30
00811727015693	Pointe Albumin on BS480 Analyzer	HORIBA INSTRUMENTS INCORPORATED	2020-05-28
10758750031771	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2020-05-16
03610230006825	Yumizen C1200 Albumin	HORIBA ABX SAS	2020-05-06
00386100002145	ALB Reagent Kit	MEDICA CORPORATION	2019-02-14
00015482771096	SPOTCHEM™ II Albumin	ARKRAY USA, INC.	2016-09-23
00015482771089	SPOTCHEM™ II Total Protein	ARKRAY USA, INC.	2016-09-23
00015482771065	SPOTCHEM™ II Total Bilirubin	ARKRAY USA, INC.	2016-09-23
04015630911516	Albumin BCG method	Roche Diagnostics GmbH	2016-09-20
04015630911523	Albumin BCG method	Roche Diagnostics GmbH	2016-09-20
04015630918898	Albumin Gen2	Roche Diagnostics GmbH	2016-09-20
04015630922581	Albumin Gen2	Roche Diagnostics GmbH	2016-09-20
04015630924820	Albumin Gen2	Roche Diagnostics GmbH	2016-09-20
04015630911509	Albumin BCG method	Roche Diagnostics GmbH	2016-09-20
03610230005187	ABX PENTRA ALBUMIN CP	HORIBA ABX SAS	2016-08-23
10758750004522	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-23
10758750000388	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-23
10758750008483	VITROS	ORTHO-CLINICAL DIAGNOSTICS, INC.	2016-08-23

Product code CIX

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