MULTIPLE MANUFACTURED BY HORIBA ABX

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MULTIPLE

Request for Information Form	Contact Information
Company Name	HORIBA ABX
Address	PARC EUROMEDECINE RUE DU CADUCEE, BP 7290
City, State, Zip	MONTPELLIER,
Country	FR
FDA Owner/Operator Phone	33-467-141516
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CGS
FDA Classification Name	NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
FDA Device Classification Code	Standards
FDA Regulation Number	862.1215
FDA Common Generic Name	CK
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9036328
FDA Owner / Operator Name	HORIBA ABX
FDA Establishment Registration Number	3000148879
FDA Registered Establishment Name	HORIBA ABX
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-18-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of HORIBA ABX

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABAXIS, INC. 3240 WHIPPLE RD. UNION CITY, CA 94587 US 510-675-6500 / 510-675-6518	CREATINE KINASE REAGENT	CREATINE KINASE TEST SYSTEM
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAY FOR DTECTION OF CREATINE KINASE
3	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS ASSAY FOR DTECTION OF CREATINE KINASE
4	ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II CPK	CREATINE PHOSPHOKINASE/CREATINE KINASE (CPK)
5	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	SPOTCHEM II CPK	CREATINE PHOSPHOKINASE/CREATINE KINASE (CPK/CK)
6	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	BECKMAN ENZYMATIC CK REAGENT KIT	CPK REAGENT KIT
7	CALDON BIOSCIENCE, INC. 2100 SOUTH RESERVOIR ST. POMONA, CA 91766 US 909-628-9944 / 909-628-9944	CREATINE KINASE	CREATINE KINASE
8	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	CAROLINA LIQUID CHEMISTRIES CREATINE KINASE REAGENT	CK
9	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	CREATINE KINASE ASSAYS	CREATINE KINASE ASSAYS
10	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 182 C K	REAGENT CREATINE KINASE
11	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	CREATINE KINASE, NAD REDUCTION
12	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	CREATINE KINASE MULTIPLE DIAGNOSIS	CREATINE KINASE MULTIPLE DIAGNOSIS
13	INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061	CREATINE KINASE	CREATINE KINASE
14	INTERSECT SYSTEMS, INC. 1152 3RD AVE. SUITE D/E LONGVIEW, WA 98632 US 360-577-1062 / 360-577-1062	CK-NAC REAGENT	CREATINE KINASE-NAC REAGENT
15	JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320	CPK (CREATINE KINASE)	CPK (CREATINE KINASE)
16	KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182	CREATINE KINASE	CREATINE KINASE
17	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	CREATINE KINASE REAGENT	CREATINE KINASE REAGENT
18	POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310	CREATINE KINASE
19	R. J. HARVEY INSTRUMENT CORP. 123 PATTERSON ST. HILLSDALE, NJ 07642 US 201-664-1380 / 201-664-1380		CPK 3430
20	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX CK NAC-ACTIVATED, RANDOX CK-MB (NAC-ACTIVATED)	CK NAC-ACTIVATED, CREATINE KINASE MB TEST
21	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX CK NAC-ACTIVATED, RANDOX CK-MB(NAC-ACTIVATED)	CK NAC-ACTIVATED, CREATINE KINASE MB TEST
22	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX CK NAC-ACTIVATED, RANDOX CK-MB (NAC-ACTIVATED)	CK-NAC-ACTIVATED, CREATINE KINASE MB TEST
23	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX CK-MB (NAL-ACTIVATED)	CREATINE KINASE MB TEST
24	ROMARK 80 EARHART DR., UNIT 3 WILLIAMSVILLE, NY 14221 US 201-664-1380 / 201-664-1380		CPK 3430
25	SEBIA PARC TECHNOLOGIQUE LEONARD DE VINCI EVRY, 91008 FR 33-169-898080 / 770-446-3707 3704	HYDRAGEL ISO-CK	ELECTROPHORESIS, CK ISOENZYMES
26	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
27	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141	CREATINE PHOSPHOKINASE (UV RATE)	CPK-UV REAGENT SET
28	SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565	SYNERMED CREATINE KINASE REAGENT KIT	CREATINE KINASE REAGENT KIT
29	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	CK-NAC REAGENT, CK REAGENT, CK-NAC REAGENT IFCC SINGLE VIAL	CREATINE PHOSPHOKINASE / CREATINE KINASE OR ISOENZYMES TEST SYSTEM
30	VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553	MULTIPLE	VARIOUS CREATINE KINASE REAGENTS
31	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES (MULTIPLE BRANDS)	OPTIMIZED METHOD (UV) FOR CREATINE KINASE DETERMINATION IN SERUM OR HEPARINAZEDA

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