DRI HEMOGLOBIN A1C CALIBRATORS MANUFACTURED BY MICROGENICS CORP.

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DRI HEMOGLOBIN A1C CALIBRATORS

Request for Information Form	Contact Information
Company Name	MICROGENICS CORP.
Address	46360 FREMONT BLVD
City, State, Zip	FREMONT, CA 94538
Country	US
FDA Owner/Operator Phone	412-490-8425
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	KRZ
FDA Classification Name	CALIBRATOR FOR HEMOGLOBIN AND HEMATOCRIT MEASUREMENT
FDA Device Classification Code	Standards
FDA Regulation Number	864.8165
FDA Common Generic Name	HEMOGLOBIN OR HEMATOCRIT MEASUREMENT CALIBRATORS
FDA Proprietary Device Name	DRI HEMOGLOBIN A1C CALIBRATORS
FDA Owner / Operator Number	2517925
FDA Owner / Operator Name	FISHER SCIENTIFIC CO., LLC.
FDA Establishment Registration Number	2937369
FDA Registered Establishment Name	MICROGENICS CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-26-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of MICROGENICS CORP.

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	ABBOTT LABORATORIES 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS HEMATOLOGY CALIBRATORS
2	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM	HEMOGLOBIN A1C PROGRAM
3	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	HAEM-CAL	MULTI-PARAMETER WHOLE BLOOD CALIBRATOR
4	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	DRI HEMOGLOBIN A1C CALIBRATORS	HEMOGLOBIN OR HEMATOCRIT MEASUREMENT CALIBRATORS
5	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413	HEMATOLOGY CALIBRATOR	HEMOGLOBIN CALIBRATOR
6	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS TYPES OF CALIBRATION SOLUTIONS
7	RADIOMETER MEDICAL APS INDUSTRIPARKEN 39-43 BALLERUP, DK-2750 DA 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS TYPES OF CALIBRATION SOLUTIONS
8	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C	CALIBRATOR
9	SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS MODELS OF BLOOD ANALYZERS
10	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	MULTIGENT HEMOGLOBIN CALIBRATORS	CALIBRATOR FOR HEMOGLOBIN OR HEMATOCRIT
11	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	HEMOGLOBIN CALIBRATOR
12	THERMO FISHER SCIENTIFIC INC. 166 CUMMINGS CENTER BEVERLY, MA 01915 US / 978-232-6000 6095	SLOPE THB SOLUTION, THB CAL DYE STANDARD	THB CAL STANDARD
13	VEGAMED, INC. EDIFICIO MULTIFABRIL #5 AVE. LAS FLORES #39 VEGA BAJA, PR 00693 US 787-807-0392 / 787-807-0392	BRU-CALIBRATOR	CALIBRATOR FOR HEMATOCRIT AND HEMOGLOBIN