CREATINE KINASE ISOENZYMES (CKMB) TESTPAK MANUFACTURED BY DADE BEHRING, INC.

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CREATINE KINASE ISOENZYMES (CKMB) TESTPAK

Request for Information Form	Contact Information
Company Name	DADE BEHRING, INC.
Address	500 GBC DR, MAILSTOP 514
City, State, Zip	NEWARK, DE 19714
Country	US
FDA Owner/Operator Phone	847-267-5300
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	CKMB
FDA Proprietary Device Name	CREATINE KINASE ISOENZYMES (CKMB) TESTPAK
FDA Owner / Operator Number	9017031
FDA Owner / Operator Name	DADE BEHRING, INC.
FDA Establishment Registration Number	2517506
FDA Registered Establishment Name	DADE BEHRING, INC.
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	02-11-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of DADE BEHRING, INC.

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. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	NO PROPRIETARY NAME LISTED	CK TEST KIT
3	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
4	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS CREATINE KINASE MB (CKMB) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY CREATINE KINASE MB
5	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
6	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
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 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)
11	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)
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. 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
15	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