QUALITROL CK/CK-MB CONTROL MANUFACTURED BY EMD CHEMICALS INC.

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QUALITROL CK/CK-MB CONTROL

Request for Information Form	Contact Information
Company Name	EMD CHEMICALS INC.
Address	480 DEMOCRAT RD.
City, State, Zip	GIBBSTOWN, NJ 08027
Country	US
FDA Owner/Operator Phone	011-49-6151726060
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JJT
FDA Classification Name	ENZYME CONTROLS (ASSAYED AND UNASSAYED)
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1660
FDA Common Generic Name	CK/CK-MB ENZYME CONTROL
FDA Proprietary Device Name	QUALITROL CK/CK-MB CONTROL
FDA Owner / Operator Number	8010686
FDA Owner / Operator Name	MERCK KGAA
FDA Establishment Registration Number	2244894
FDA Registered Establishment Name	EMD CHEMICALS INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of EMD CHEMICALS 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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	CONTROL MATERIAL
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	CARDIAC QC ON THE ACCESS (R) IMMUNOASSAY SYSTEM	QUALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
3	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	MULTIPLE (QUANTEX ASO-CRP-RF CONTROL)	RHEUMA TEST CONTROLS
4	BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. IRVINE, CA 92618 US 510-724-7000 / 949-598-1200	MULTIPLE	VARIOUS
5	CLINICAL CONTROLS INTERNATIONAL 1236 LOS OSOS VALLEY ROAD SUITE T LOS OSOS, CA 93402 US 805-528-4039 / 805-528-4039	MULTIPLE TYPES OF ENZYME CONTROLS:CARDIOSPX (R) CKMB/LD-1 IMMUNOHIBITION CONTROL	VARIOUS TYPES OF ENZYME CONTROLS: CKMB/LD-1 IMMUNOHIBITION CONTROL
6	CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD. SAN MARCOS, CA 92069 US 760-744-1900 / 760-744-1900 112	LIQUID QC CARDIAC MARKER CONTROL	LIQUID QC CARDIAC MARKER CONTROL
7	CREATIVE LABORATORY PRODUCTS, INC. 6420 N.GUIAN RD. INDIANAPOLIS, IN 46268 US 317-293-2991 / 317-293-2991	CK ISOENZYME CONTROL	CREATINE KINASE CONTROL
8	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	ENZYME CONTROLS (ASSAYED AND UNASSAYED)	ENZYME CONTROLS (ASSAYED AND UNASSAYED)
9	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CARDIOIMMUNE TL CARDIAC MARKER CONTROL	LIQUID ASSAYED CARDIAC CONTROL
10	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CARDIOIMMUNE TL CARDIAC MARKER CONTROL	LIQUID ASSAYED CARDIAC CONTROL
11	MYERS-STEVENS GROUP 2931 VAIL AVE. COMMERCE, CA 90040 US 323-721-8552 / 903-566-6696	V-TREND OC CPK	CPK ENZYME CONTROLS
12	NANOGEN POINT-OF-CARE (POC) DIAGNOSTICS DIVISION 135-2 THE WEST MALL TORONTO, ONTARIO, M9C 1C2 CA 416-621-3445 / 858-410-4683	CARDIAC STATUS CONTROLS (CKMB/MYOGLOBIN)	CARDIAC STATUS CONTROLS (CKMB/MYOGLOBIN)
13	QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD. REDONDO BEACH, CA 90278 US 310-536-0006 / 310-536-0006	CARDIASURE ASSAYED CARDIAC MARKERS CONTROL	CARDIAC MARKERS CONTROL
14	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	MULTIPLE	MULTIENZYME CONTROLS
15	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIPLE	VARIOUS ASSAYEDAND UNASSAYED ENZYME CONTROLS
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
17	VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. PROVIDENCE, RI 02907 US 401-461-0180 / 401-461-0180	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED