ACCUSPORT PORTABLE ANALYZER AND LACTATE TEST STRIPS MANUFACTURED BY ROCHE DIAGNOSTICS CORP.

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ACCUSPORT PORTABLE ANALYZER AND LACTATE TEST STRIPS

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS CORP.
Address	9115 HAGUE RD.
City, State, Zip	INDIANAPOLIS, IN 46250
Country	US
FDA Owner/Operator Phone	--
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	KHP
FDA Classification Name	ACID, LACTIC, ENZYMATIC METHOD
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1450
FDA Common Generic Name	LACTATE TEST
FDA Proprietary Device Name	ACCUSPORT PORTABLE ANALYZER AND LACTATE TEST STRIPS
FDA Owner / Operator Number	1823260
FDA Owner / Operator Name	ROCHE HOLDING, INC.
FDA Establishment Registration Number	1823260
FDA Registered Establishment Name	ROCHE DIAGNOSTICS CORP.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	08-22-95
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS 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 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS
2	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	MULTIPLE	VARIOUS
3	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	ACID, LACTIC, ENZYMATIC METHOD	LACTATE TEST
4	ABBOTT POINT OF CARE CANADA LIMITED 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	ACID, LACTIC, ENZYMATIC METHOD	LACTATE TEST
5	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	ACID, LACTIC, ENZYMATIC METHOD	LACTATE TEST
6	APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU, 30078 TW 886-3-5641952 / 952-646-3168	THE EDGE BLOOD LACTATE MONITORING SYTEM	LACTIC ACID TEST SYSTEM
7	AREYOUPREGNANT.COM 2606 REDBUD ST. KILGORE, TX 75662 US 903-988-0616 / 903-988-0616	MULTIPLE	OVULATION TEST STRIP, FERTILITY TEST
8	ARKRAY FACTORY INC. 7-5-6 OGAKI RITTO-SHI, SHIGA, 520-3024 JA 81-75-6628964 / 81-748-867298	LACTATE PRO SYSTEM	TEST FOR LACTATE IN WHOLE BLOOD
9	ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298	LACTATE PRO SYSTEM	TEST FOR LACTATE IN WHOLE BLOOD AND BLOOD L
10	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	LACTIC ACID
11	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	LACTIC ACID
12	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS LACTIC ACID METHODS
13	DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 HOLZHEIM, RHEINLAND-PFALZ, D-65558 GM 49-643-291460 / 954-433-7480 144	LACTATE FS	LACTATE
14	HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92	MULTIPLE	LACTIC ACID
15	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02421 US 781-861-4467 / 781-861-4467	MULTIPLE: SYNTHESIS, ELECTRODES, ETC.	LACTIC TEST SYSTEM
16	INTERNATIONAL TECHNIDYNE INCORPORATED 2656 PATTON RD. ROSEVILLE, MN 55113 US 732-548-5700 / 732-548-5700 265	IRMA TRUPOINT LACTATE CARTRIDGE	IRMA LACTATE CARTRIDGE
17	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	STAT PROFILE PLUS 7,9,10 ANALYZERS	STAT PROFILE PLUS 7,9,10 ANALYZERS
18	ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	MULTIPLE	LACTIC ACID TEST SYSTEM
19	PANASONIC SHIKOKU ELECTRONICS CO., LTD. 2131-1 MINAMIGATA, TOON, EHIME, 791-0395 JA 81-89-96611-2822 / 81-89-9661163	LACTATE PRO SYSTEM	TEST FOR LACTATE IN WHOLE BLOOD AND BLOOD LACTATE TEST METER
20	PANASONIC SHIKOKU ELECTRONICS CO., LTD. 110 OAZA-INOSHIRI AZA-NISHIUENO WAKIMACHI,MIMA,TOKUSHIMA, 779-3603 JA 81-89-96611-2822 / 81-89-9661163	LACTATE PRO SYSTEM	TEST FOR LACTATE IN WHOLE BLOOD AND BLOOD LACTATE TEST METER
21	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617	MULTIPLE	VARIOUS MODELS OF BLOOD ANALYZERS
22	SENSLAB GESELLSCHAFT ZUR ENTWICKLUNG UND HERSTELLU BAUTZNER STR. 67 LEIPZIG, D-04347 GM 49-341-2341848 / 49-341-2341842	LACTATE SCOUT	LACTIC ACID TEST SYSTEM
23	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	LACTIC ACID ASSAY
24	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR. NORWOOD, MA 02062 US 914-524-2955 / 508-660-8540	MULTIPLE	LACTIC ACID METHOD
25	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	LACTATE REAGENT, LACTATE STANDARDS	LACTIC ACID TEST SYSTEM
26	YSI INCORPORATED 1725 BRANNUM LN. YELLOW SPRINGS, OH 45387 US 937-767-7241 / 937-767-7241 255	YSI 1500 SPORT LACTATE ANANLYZER	YSI 1500 SPORT LACTATE ANANLYZER