CREATININE LIQUICOLOR MANUFACTURED BY STANBIO LABORATORY

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CREATININE LIQUICOLOR

Request for Information Form	Contact Information
Company Name	STANBIO LABORATORY
Address	1261 NORTH MAIN ST.
City, State, Zip	BOERNE, TX 78006
Country	US
FDA Owner/Operator Phone	830-249-0772
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
FDA Proprietary Device Name	CREATININE LIQUICOLOR
FDA Owner / Operator Number	1616487
FDA Owner / Operator Name	STANBIO LABORATORY
FDA Establishment Registration Number	1616487
FDA Registered Establishment Name	STANBIO LABORATORY
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	08-10-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of STANBIO LABORATORY

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 CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	IRMA TRUPOINT CR CARTRIDGE	CREATININE TEST SYSTEM
6	INTERNATIONAL TECHNIDYNE INCORPORATED 2656 PATTON RD. ROSEVILLE, MN 55113 US 732-548-5700 / 732-548-5700 265	IRMA TRUPOINT CR CARTRIDGE	CREATININE TEST SYSTEM
7	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)
8	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	CREATININE TEST SYSTEM
9	POLYMER TECHNOLOGY SYSTEMS, INC. 7736 ZIONSVILLE RD. INDIANAPOLIS, IN 46268 US 317-870-5610 / 317-870-5610	BIOSCANNER CREATININE TEST STRIPS	CREATININE TEST
10	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANDOX ENZYMATIC CREATININE	ENZYMATIC CREATININE
11	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
12	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	CREATININE ENZYMATIC	CREATININE
13	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
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955	CLINITEK MICROALBUMIN/CREATININE	TEST FOR MICROALBUMIN
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