VIDAS CREATINE KINASE MB (CKMB) ASSAY MANUFACTURED BY BIOMERIEUX SA

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VIDAS CREATINE KINASE MB (CKMB) ASSAY

Request for Information Form	Contact Information
Company Name	BIOMERIEUX SA
Address	CHEMIN DE L'ORME
City, State, Zip	MARCY L'ETOILE,
Country	FR
FDA Owner/Operator Phone	33-478-872063
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JHX
FDA Classification Name	FLUOROMETRIC METHOD, CPK OR ISOENZYMES
FDA Device Classification Code	Standards
FDA Regulation Number	862.1215
FDA Common Generic Name	ENZYME-LINKED FLUORESCENT IMMUNOASSAY CREATINE KINASE MB
FDA Proprietary Device Name	VIDAS CREATINE KINASE MB (CKMB) ASSAY
FDA Owner / Operator Number	8020790
FDA Owner / Operator Name	BIOMERIEUX SA
FDA Establishment Registration Number	8020790
FDA Registered Establishment Name	BIOMERIEUX SA
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-19-96
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of BIOMERIEUX SA

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	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	AMRESCO CK-NAC REAGENT	CREATINE REAGENT
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS	CK-MB ENZYME IMMUNOASSAY
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	NO PROPRIETARY NAME LISTED	CK TEST KIT
4	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS CREATINE KINASE MB (CKMB) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY CREATINE KINASE MB
5	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423	TRIAGE CARDIAC PANEL	FLUORESCENCE IMMUNOASSAY FOR CKMB,TROPININ I AND MYOGLOBIN
6	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	CREATINE KINASE ISOENZYMES (CKMB) TESTPAK	CKMB
7	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	ARCHITECT STAT CK-MB IMMUNOASSAY REAGENTS	CK-MB IMMUNOASSAY REAGENTS
8	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENTS PACK	CKMB TEST SYSTEM
9	RESPONSE BIOMEDICAL CORP. 100 - 8900 GLENLYON PARKWAY BURNABY, BRITISH COLUMBIA, V5J 5J8 CA 604-456-6010 / 604-456-6010 x6045	RAMP CK-MB ASSAY	FLUOROMETRIC METHOD, CPK OR ISOENZYMES
10	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500, IML TURBO CK-MB	IMMUNOASSAY FOR MEASUREMENT OF CK-MB (MONO-MONO)
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE, IML 1000, IML 2000, IML 2500, IML TURBO CK-MB	IMMUNOASSAY FOR MEASUREMENT OF CK-MB (MONO-MONO)
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	IMMULITE,IML 2000,IML 2500, IML TURBO CK-MB	IMMUNOASSAY FOR THE MEASUREMENT OF CK-MB
13	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK CKMB, ST AIA-PACK CKMB	FOR THE MEASUREMENT OF CREATINE KINASE MB ISOENZYME, CKMB
14	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	AIA-PACK CKMB, ST AIA-PACK CKMB	CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM
15	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK CKMB, ST AIA-PACK CKMB	FOR THE MEASUREMENT OF CREATINE KINASE MB ISOENZYME, CKMB