IRMA TRUPOINT CR CARTRIDGE MANUFACTURED BY INTERNATIONAL TECHNIDYNE CORPORATION

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IRMA TRUPOINT CR CARTRIDGE

Request for Information Form	Contact Information
Company Name	INTERNATIONAL TECHNIDYNE CORPORATION
Address	20 CORPORATE PLACE SOUTH
City, State, Zip	PISCATAWAY, NJ 08854
Country	US
FDA Owner/Operator Phone	732-548-5700
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JFY
FDA Classification Name	ENZYMATIC METHOD, CREATININE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1225
FDA Common Generic Name	CREATININE TEST SYSTEM
FDA Proprietary Device Name	IRMA TRUPOINT CR CARTRIDGE
FDA Owner / Operator Number	2250033
FDA Owner / Operator Name	INTERNATIONAL TECHNIDYNE CORPORATION
FDA Establishment Registration Number	3005776351
FDA Registered Establishment Name	INTERNATIONAL TECHNIDYNE CORPORATION
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	05-24-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of INTERNATIONAL TECHNIDYNE CORPORATION

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	BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372	MULTISTIX PRO 10 LS	TEST FOR LEUKOCYTES,NITRITE,BLOOD,PH,CREATININE,SG,KETONE,PROTEIN LOW/HIGH,
2	BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430	MULTISTIX PRO 10 LS	TEST FOR LEUKOCYTES,NITRITE,BLOOD,PH,CREATININE,SG,KETONE,PROTEIN LOW/HIGH,
3	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	ENZYMATIC CREATININE ASSAY	ENZYMATIC CREATININE ASSAY
4	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501	ANALYST CREATININE	ANALYST CREATININE
5	INTERNATIONAL TECHNIDYNE INCORPORATED 2656 PATTON RD. ROSEVILLE, MN 55113 US 732-548-5700 / 732-548-5700 265	IRMA TRUPOINT CR CARTRIDGE	CREATININE TEST SYSTEM
6	KIMBALL ELECTRONICS (WALES) LIMITED WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES, CF31 3TY UK 812-634-4172 / 44-163-5566448	MULTISTIX PRO 10 LS	LEUKOCYTES,NITRITE,BLOOD,PH,CREATININE,SG,PRO(LOW/HIGH)
7	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	CREATININE TEST SYSTEM
8	POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. INDIANAPOLIS, IN 46268 US 317-870-5610 / 317-870-5610	BIOSCANNER CREATININE TEST STRIPS	CREATININE TEST
9	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX ENZYMATIC CREATININE	ENZYMATIC CREATININE
10	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM	REAGENT FOR ENZYMATIC DETERMINATION OF CREATININE IN SERUM
11	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	CREATININE ENZYMATIC	CREATININE
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA 1650 CREATININE, ENYMATIC ASSAY	CREATININE, ENYMATIC ASSAY
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955	CLINITEK MICROALBUMIN/CREATININE	TEST FOR MICROALBUMIN
14	STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772	CREATININE LIQUICOLOR	CREATININE TEST
15	THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100	CREATININE ENZYMATIC REAGENT	CREATININE ENZYMATIC REAGENT
16	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-PACK CK-MB	CREATINE TEST SYSTEM
17	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	CREATININA CINETICA AA	TEST SYSTEM TO MEASURE CREATININE IN PLASMA AND URINE