Bromcresol Green Dye-Binding, Albumin

FDA product code CIX · 120 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1035
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-05 – 2026-01-09

CIX 2026-01-09

Core Metabolic

Applicant Truvian Health

K number K251157

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CIX 2021-11-23

Albumin BCG2

Applicant Abbott Ireland Diagnostics Division

K number K203248

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CIX 2021-09-21

Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin

Applicant Medicon Hellas S.A

K number K200898

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CIX 2019-06-07

VITROS XT Chemistry Products ALB-TP Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K number K191316

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CIX 2018-04-13

ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

Applicant Biosystems S.A.

K number K170901

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CIX 2013-08-19

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

Applicant Alfa Wassermann Diagnostics Technologies, LLC

K number K131488

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CIX 2012-07-13

ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K113374

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CIX 2011-09-08

POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

Applicant Polymedco, Inc.

K number K110818

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CIX 2011-06-21

ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

Applicant Elitechgroup

K number K110830

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CIX 2011-04-04

EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT

Applicant Medica Corp.

K number K101088

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CIX 2009-02-20

EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

Applicant Medica Corp.

K number K080874

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CIX 2008-07-14

S40 CLINICAL ANALYZER, S TEST ALB

Applicant Alfa Wassermann Diagnostic Technologies, Inc.

K number K072143

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CIX 2007-06-05

ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL

Applicant Horiba Abx

K number K060434

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CIX 2003-10-16

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

Applicant Roche Diagnostics Corp.

K number K033009

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CIX 2003-03-07

ATAC PAK ALBUMIN REAGENT

Applicant Elan Diagnostics

K number K030006

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CIX 2002-12-10

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

Applicant Ortho-Clinical Diagnostics, Inc.

K number K023875

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CIX 2002-08-23

PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS

Applicant Precision Systems, Inc.

K number K022072

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CIX 2001-09-21

WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120 ML CAT 1009300

Applicant Wiener Laboratories Saic

K number K012329

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CIX 2001-06-25

OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER

Applicant Olympus America, Inc.

K number K011720

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CIX 2001-05-23

CHEMWELL, MODEL 2900

Applicant Awareness Technology, Inc.

K number K010877

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CIX 2000-12-05

ALBUMIN

Applicant Jas Diagnostics, Inc.

K number K003327

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CIX 1999-09-15

ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K992399

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CIX 1999-06-30

ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

Applicant Bayer Corp.

K number K991576

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CIX 1999-03-23

RANDOX ALBUMIN

Applicant Randox Laboratories, Ltd.

K number K984494

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CIX 1998-06-12

ALBG

Applicant Abbott Laboratories

K number K981758

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CIX 1998-05-27

ALBG

Applicant Abbott Laboratories

K number K981468

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CIX 1998-02-04

CARESIDE ALBUMIN

Applicant Exigent Diagnostics, Inc.

K number K980041

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CIX 1997-05-02

ALB OR ALBUMIN

Applicant Carolina Liquid Chemistries Corp.

K number K971445

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CIX 1996-03-13

ALBUMIN

Applicant Derma Media Lab., Inc.

K number K955781

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CIX 1995-10-13

TRACE COBAS MIRA RANGE

Applicant Trace Scientific , Ltd.

K number K952488

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CIX 1995-03-01

DMA ALBUMIN PROCEDURE

Applicant Data Medical Associates, Inc.

K number K946355

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CIX 1994-12-13

ALBUMIN QVET

Applicant Prisma Systems

K number K943000

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CIX 1993-12-17

EMDS ALBUMIN (ALB) TEST

Applicant Em Diagnostic Systems, Inc.

K number K935179

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CIX 1993-02-08

OLYMPUS ALBUMIN REAGENT

Applicant Olympus Corp.

K number K924368

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CIX 1992-12-28

ALBUMIN TEST

Applicant Em Diagnostic Systems, Inc.

K number K923959

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CIX 1992-09-11

TRACE ALBUMIN-MR REAGENT

Applicant Trace Scientific , Ltd.

K number K923322

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CIX 1992-07-17

OLYMPUS ALBUMIN REAGENT

Applicant Olympus Corp.

K number K922369

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CIX 1991-11-27

TECHNICON CHEM 1(TM) SYST (GEN2 SYST)

Applicant Technicon Instruments Corp.

K number K914888

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CIX 1991-09-27

ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37

Applicant Em Diagnostic Systems, Inc.

K number K913920

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CIX 1991-08-26

KODAK EKTACHEM DT SLIDES (ALB)

Applicant Eastman Kodak Company

K number K913195

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CIX 1991-01-25

SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401

Applicant Em Diagnostic Systems, Inc.

K number K905660

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CIX 1990-10-12

SYNERMED ALBUMIN REAGENT KIT

Applicant Synermed, Inc.

K number K903543

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CIX 1990-05-30

COULTER ALBUMIN REAGENT

Applicant Coulter Corp.

K number K901268

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CIX 1990-02-27

COBAS READY ALBUMIN REAGENT

Applicant Roche Diagnostic Systems, Inc.

K number K896235

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CIX 1990-01-18

CLINISTAT ALBUMIN REAGENT TEST

Applicant Miles Diagnostics Div.

K number K896910

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CIX 1989-08-21

ALBUMIN TEST (ALB) ITEM NUMBER: 65401

Applicant Em Diagnostic Systems, Inc.

K number K893777

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CIX 1989-05-05

IQ ALBUMIN

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K891375

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CIX 1989-02-10

BIOTROL ALBUMIN

Applicant Biotrol, USA, Inc.

K number K885094

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CIX 1989-01-11

ALBUMIN TEST (ALB) ITEM #65650

Applicant Em Diagnostic Systems, Inc.

K number K884705

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CIX 1988-08-08

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM

Applicant A-Kem, Inc.

K number K882587

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CIX 1988-04-18

ALBUMIN CAT. # 201-03

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K875207

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CIX 1988-04-05

ALBUMIN REAGENT SET

Applicant Tech-Neal Scientific, Inc.

K number K880844

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CIX 1988-03-24

WAKO(TM) AUTOKIT ALBUMIN

Applicant Wako Chemicals USA, Inc.

K number K880313

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CIX 1988-01-11

ALBUMIN, BROMCRESOL GREEN DYE-BINDING

Applicant Tech-Co, Inc.

K number K875070

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CIX 1987-11-23

ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS

Applicant Catachem, Inc.

K number K874163

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CIX 1987-10-29

MULTICHEM ALBUMIN REAGENT S0902

Applicant Simmler, Inc.

K number K874049

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CIX 1987-10-29

EASY-TEST ALBUMIN (ALB), ITEM NO. 19039

Applicant Em Diagnostic Systems, Inc.

K number K873994

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CIX 1987-08-19

ALBUMIN REAGENT - BROMCRESOL GREEN METHOD

Applicant Trace Scientific , Ltd.

K number K870372

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CIX 1986-12-31

EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93

Applicant Em Diagnostic Systems, Inc.

K number K864715

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CIX 1986-09-15

ALBUMIN PROCEDURE

Applicant Data Medical Associates, Inc.

K number K863263

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CIX 1986-09-11

ALBUMETER

Applicant J. D. Assoc.

K number K863050

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CIX 1986-06-13

ALBUMIN PROCEDURE

Applicant Data Medical Associates, Inc.

K number K861654

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CIX 1986-05-23

ALBUMIN (BCG) REAGENT

Applicant Sigma Diagnostics, Inc.

K number K861467

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CIX 1986-03-17

SANDARE BCG ALBUMIN PROCEDURE

Applicant Sandare Chemical Co., Inc.

K number K860684

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CIX 1986-03-14

AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT

Applicant Amresco, Inc.

K number K860661

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CIX 1986-02-19

SERUM ALBUMIN (BCG) REAGENT SET

Applicant Sterling Diagnostics, Inc.

K number K860340

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CIX 1986-02-11

ALBUMIN REAGENT KIT

Applicant Bio-Analytics Laboratories, Inc.

K number K860213

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CIX 1986-01-14

ALBUMIN REAGENT SET

Applicant Technostics Intl.

K number K855158

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CIX 1985-12-19

NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926

Applicant Nobel Scientific Industries, Inc.

K number K854718

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CIX 1985-11-25

IN-VITRO TEST DETERMINATION OF ALBUMIN

Applicant Clinical Data, Inc.

K number K854181

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CIX 1985-10-15

TDX AMYLASE

Applicant Abbott Laboratories

K number K853978

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CIX 1985-09-30

ALBUMIN SR LIQUID STABLE REAGENT SET

Applicant Medical Analysis Systems, Inc.

K number K853868

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CIX 1985-08-02

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE

Applicant Simmler, Inc.

K number K853049

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CIX 1985-06-26

ALBUMIN

Applicant Dilab, Inc.

K number K850931

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CIX 1985-05-30

ALB BCG REAGENT

Applicant Alpkem Corp.

K number K852007

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CIX 1985-04-17

ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S

Applicant Technicon Instruments Corp.

K number K851308

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CIX 1985-01-03

ALBUMIN REAGENT FOR DEMAND ANALYZER

Applicant Advanced Biomedical Methods, Inc.

K number K844330

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CIX 1984-10-11

ALBUMIN REAGENT SET

Applicant Livonia Diagnostics, Inc.

K number K843831

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CIX 1984-09-07

ALBUMIN ASSAY KIT

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K843104

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CIX 1984-08-27

SYSTEMATE ALBUMIN

Applicant Em Diagnostic Systems, Inc.

K number K843108

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CIX 1984-05-01

ALBUMIN REAGENT SET

Applicant Medical Specialties, Inc.

K number K841063

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CIX 1984-04-13

ALBUMIN REAGENT

Applicant American Dade

K number K840782

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CIX 1984-03-30

MCS ALBUMIN REAGENT

Applicant Medilab Corp.

K number K840291

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CIX 1984-01-13

ALBUMIN REAGENT CS-716

Applicant Fisher Scientific Co., LLC

K number K833699

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CIX 1983-10-14

ALBUMIN REAGENT SET

Applicant Biorent Diagnostic, Inc.

K number K832747

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CIX 1983-06-16

ALBUMIN REAGENT (BCG

Applicant Reagents Applications, Inc.

K number K831585

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CIX 1983-03-24

FLOW-PAC ALBUMIN REAGENT

Applicant Amresco, Inc.

K number K830536

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CIX 1983-01-07

COBAS STANDARDS FOR ALBUMIN

Applicant Hoffmann-La Roche, Inc.

K number K823575

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CIX 1983-01-07

COBAS REAGENT FOR ALBUMIN

Applicant Hoffmann-La Roche, Inc.

K number K823574

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CIX 1982-09-14

PSI ALBUMIN REAGENT

Applicant Pointe Scientific, Inc.,

K number K822471

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CIX 1982-07-14

ULTRA CHEM ALB

Applicant Harleco Diagnostics

K number K821880

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CIX 1982-07-13

ALBUMIN REAGENT SET

Applicant Omega Medical Electronics

K number K821193

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CIX 1982-05-21

ALBUMIN REAGENT

Applicant Hi Chem, Inc.

K number K821225

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CIX 1981-11-10

ULTRACHEM ALB, ITEM #64970

Applicant Harleco

K number K813044

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CIX 1981-08-03

KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)

Applicant Eastman Kodak Company

K number K812030

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CIX 1981-06-25

ALBUMIN TEST

Applicant King Diagnostics, Inc.

K number K811662

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CIX 1981-01-09

AMES SERA-PAK ALBUMIN REAGENT KIT

Applicant Miles Laboratories, Inc.

K number K803237

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CIX 1980-10-31

CENTRIFICHEM ALBUMIN

Applicant Union Carbide Corp.

K number K802436

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CIX 1980-10-10

BCG REAGENT SERUM ALBUMIN W/TECHNICON

Applicant Panmed, Inc.

K number K802157

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CIX 1980-09-16

BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY

Applicant Beckman Instruments, Inc.

K number K801750

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