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ELECSYS 2010 ANALYZER
 Request for Information Form |
 Contact Information
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| 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 | JJE |
| FDA Classification Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 862.2160 |
| FDA Common Generic Name | CLINICAL ANALYZER |
| FDA Proprietary Device Name | ELECSYS 2010 ANALYZER |
| 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 |
| FDA Listing Date | 11-13-97 |
| 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 1921 HURD DR. IRVING, TX 75038 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS |
| 3 | ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS MODELS OF BICHROMATIC PHOTOMETRIC ANALYZERS |
| 4 | ADALTIS ITALIA S.P.A., LABORATORY INSTRUMENTS PLAN VIA TIBURTINA VALERIA-KM.18, 200 GUIDONIA MONTECELIO ROME, 00012 IT 514-335-9922 / 610-264-0885 221 |
IMMUNOASSAY ANALYZERS (MULTIPLE BRANDS) | VARIOUS IMMUNOASSAY ANALYZERS |
| 5 | ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922 |
MULTIPLE | VARIOUS |
| 6 | ALFA BIOTECH (UK) LTD., SYSTEMS DIV. STATION APPROACH, BEKESBOURNE NR CANTERBURY, KENT, CT4 5DT UK 39-51-64 89 511 / 012-52-341477 |
AURAFLEX SYSTEM | AURAFLEX SYSTEM |
| 7 | AMS S.R.L. ANALYZER MEDICAL SYSTEM 17/A VIA E. BARSANTI GUIDONIA (ROME), I-00012 IT 39-077-4354441 / 39-077-4354441 |
LIASYS AND ELLIPSE | VARIOUS TYPES OF CLINICAL CHEMISTRY ANALYZERS |
| 8 | ANDERCRAFT DE MEXICO, S.A. DE C.V. CERRADA VIA DE LA PRODUCCION #84 MEXICALI,BAJA CALIFORNIA, 21600 MX 011-526-865625000 / 702-617-8055 |
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE#CLINICAL CHEMISTRY | ALCYON CUVETTE |
| 9 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
ACCESS 2 IMMUNOASSAY SYSTEM | MULTIPLE |
| 10 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | CHEMISTRY ANALYZER |
| 11 | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. BREA, CA 92821 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | CHEMISTRY ANALYZER |
| 12 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | CHEMISTRY ANALYZER |
| 13 | BIOCHEMIMMUNOSYSTEMS ITALIA S.P.A. VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, IT |
IMMUNOASSAY ANALYZER, MULTIPLE BRANDS | IMMUNOASSAY ANALYZER, VARIOUS TYPES |
| 14 | BIOMERIEUX ITALIA-INDUSTRIAL DIV. VIA DI CAMPIGLIANO 58 PONTE-A EMA, FLORENCE, 50015 IT 33-478-872063 / 314-731-8594 |
MINI VIDAS INSTRUMENT | DISCRETE WAVELENGTH FLUOROMETER |
| 15 | BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594 |
MICROPLATE PROCESSOR 3000 | MICROPLATE PROCESSOR |
| 16 | BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US 33-478-872063 / 314-731-8594 |
MICROPLATE PROCESSOR 3000 | MICROPLATE PROCESSOR |
| 17 | BIOTECNICA INSTRUMENTS, SPA VIA LICENZA 18 ROME, 00156 IT 39-06-4112316 / 714-672-3553 |
ATAC 6000 | CHEMISTRY SYSTEM, PHOTOMETRIC DISCRETE |
| 18 | CGA STRUMENTI SCIENTIFICI S.P.A. VIA LUCA GIORDANO, 7/B/ FLORENCE, 50132 IT 011-390-555048335 / 727-669-7771 |
EOS 880C | AUTOMATIC CLINICAL CHEMISTRY PHOTOMETER |
| 19 | CHEMDEV INSTRUMENTS, INC. 1289 REAMWOOD AVE., #B SUNNYVALE, CA 94089 US 408-541-8535 / 408-541-8535 |
ECO CHEM 300 | ECO CHEM 300 CHEMISTRY SYSTEM |
| 20 | COVANCE RESEARCH PRODUCTS, INC. 180 RUSTCRAFT RD., SUITE 140 DEDHAM, MA 02026 US 800-922-2226 / 781-915-1405 |
BRST-2 MONOCLONAL ANTIBODY | D6, MONOCLONAL ANTIBODY |
| 21 | CRONY INSTRUMENTS S.R.L. VIA TIBURTINA 661 ROME, 00159 IT 39-06-4396432 / 843-277-1642 |
VARIOUS/MULTIPLE | CHEMISTRY ANALYZER (DISCRETE PHOTOMETRIC) FOR CLINICAL USE |
| 22 | DADE BEHRING, INC. 101 SILVERMINE RD. BROOKFIELD, CT 06804 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS CLINICAL CHEMISTRY SYSTEMS AND ACCESSORIES |
| 23 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS CLINICAL CHEMISTRY SYSTEMS AND ACCESSORIES |
| 24 | DIAGNOSTIC GRIFOLS, S.A. PASSEIG FLUVIAL, 24 PARETS DEL VALLES, BARCELONA, 08150 SP 34-935-710400 / 34-935-710215 |
TRITURUS | IMMUNOASSAY ANALYZER |
| 25 | DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. HOLLISTON, MA 01746 US 508-429-0450 / 508-429-0450 |
ABBOTT AEROSET | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER |
| 26 | DIASYS DIAGNOSTICS SYSTEMS GMBH ALTE STRASSE 9 HOLZHEIM, RHEINLAND-PFALZ, D-65558 GM 49-643-291460 / 954-433-7480 144 |
STARDUST MC15 | CHEMISTRY ANALYZER |
| 27 | DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM |
LCK 142 ERYTHROCYTES | REAGENT ERYTHROCYTES |
| 28 | EPPENDORF AG BARKHAUSENWEG 1 HAMBURG, 22339 GM 49-40-538010 / 49-40-53801800 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 29 | HAMILTON CO. 4970 ENERGY WAY RENO, NV 89502 US 775-858-3000 236 / 775-858-3000 236 |
MICROLAB F.A.M.E.,ORTHO SUMMIT PROCESSOR | MICROLAB F.A.M.E.,ORTHO SUMMIT PROCESSOR |
| 30 | HEMODIAGNOSTICA, LLC 345 FRESHFIELDS DR. JOHNS ISLAND, SC 29455 US 843-277-1642 / 843-277-1642 |
VARIOUS/MULTIPLE | CHEMISTRY ANALYZER (DISCRETE PHOTOMETRIC) FOR CLINICAL USE |
| 31 | HITACHI HIGH-TECH SCIENCE SYSTEMS CORPORATION 1040 ICHIGE HITACHINAKA-SHI, JA 81-335-045836 / 81-29-3544029 |
BM/HITACHI 902 AUTOMATIC ANALYZER | AUTOMATED CLINICAL CHEMISTY ANALYZER |
| 32 | HITACHI HIGH-TECHNOLOGIES CORP., NAKA DIVISION 882 ICHIGE HITACHINAKA, IBARAKI, 312-8504 JA 81-335-045836 / 813-350-45836 |
ELECSYS 2010 ANALYZER | AUTOMATED CLINICAL CHEMISTRY ANALYZER |
| 33 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | CLINICAL CHEMISTRY ANALYZERS |
| 34 | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02421 US 781-861-4467 / 781-861-4467 |
IL682, CO-OXIMETER | CO-OXIMETER |
| 35 | JEOL, LTD. 1-2 MUSASHINO, 3-CHOME AKISHIMA, TOKYO, 196-8558 JA 042-542-2272 / 81-42-542 2313 |
JCA-BM12/B,JCA-BM2400/B | JCA-BM12/B,JCA-BM2400/B |
| 36 | LABCON, NORTH AMERICA 3700 LAKEVILLE HWY., STE. 200 PETALUMA, CA 94954 US 409-842-3714 / 707-766-2106 |
AUTO ANALYSIS CUP | AUTO ANALYSIS CUP |
| 37 | LAB-INTERLINK, INC. 8950 J STREET OMAHA, NE 68127 US 705-860-1220 / 402-595-3767 2280 |
AWCC SOFTWARE | AWCC-AUTOMATED WORKCELL CONTROL SYSTEM |
| 38 | MISHIMA OLYMPUS CO., LTD. 454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 3-334-02111 / 484-896-5688 |
OLYMPUS CHEMISTRY ANALYZERS | CLINICAL CHEMISTRY ANALYZERS |
| 39 | NOVX SYSTEMS INC. 185 RENFREW DRIVE MARKHAM, ONTARIO, L3R 6G3 CA 905-474-5051ext240 / 905-474-5051x240 |
IMDX ANALYZER | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| 40 | ORTHO-CLINICAL DIAGNOSTICS, INC. 300 WEILAND RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
MULTIPLE | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| 41 | ORTHO-CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. ROCHESTER, NY 14626 US 585-453-4469 / 585-453-3768 |
MULTIPLE | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE |
| 42 | ORTHO-CLINICAL DIAGNOSTICS, INC. ROUTE 202 RARITAN, NJ 08869 US 908-218-8177 / 908-218-8177 |
ORTHO SUMMIT SYSTEM/ORTHO SUMMIT PROCESSOR | MICROPLATE ASSAY TEST PROCEDURE PROCESSING SYSTEM |
| 43 | PHADIA AB RAPSGATAN 7 UPPSALA, SE-754 50 SW 46-18-165000 / 46-18-163775 |
IMMUNOCAP 100E, IMMUNOCAP 250, IMMUNOCAP 1000 | DISCRETE PHOTOMETRIC ANALYZERS FOR CLINICAL USE |
| 44 | PRECISION SYSTEM SCIENCE CO., LTD. 88 KAMIHONGOU MATSUDO-SHI, CHIBA, 271-0064 JA 81-47-3034800 / 81-47-3034802 |
PATHFAST | IMMUNOASSAY ANALYZER |
| 45 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
EVIDENCE AUTOMATED IMMUNOASSAY ANALYZER | CHEMISTRY ANALYZER |
| 46 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
EVIDENCE AUTOMATED IMMUNOASSAY ANALYZER | CHEMISTRY ANALYZER |
| 47 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
EVIDENCE AUTOMATED IMMUNOASSAY ANALYSER | CHEMISTRY ANALYSER |
| 48 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RX IMOLA | CHEMISTRY ANALYSER |
| 49 | ROBION AG GEWERBESTRASSE 6 NEUHAUSEN AM RHEINFALL, SH, 8212 SZ 41-526-700955 / 41-52-6700955 |
ADIVA CENTAUR CP | CLINICAL ANALYZER |
| 50 | ROCHE DIAGNOSTICS GMBH FRIEDRICH-EBERT-STRABE 100 MANNHEIM, 68167 GM 49-621-7670 / 317-521-2834 |
REFLOTRON PLUS, REFLOTRON SPRINT | REFLOTRON PLUS, REFLOTRON SPRINT |
| 51 | ROCHE DIAGNOSTICS LTD. FORRENSTRASSE ROTKREUZ, CH-6343 SZ 49-621-7670 / 317-521-2834 |
COBAS CORE II, ELECSYS 1010 ANALYZER, COBAS INTEGRA 400 PLUS,COBAS INTEGRA 800 | CLINICAL ANALYZER |
| 52 | SDI BIOMED, INC. 9428 ETON AVENUE, UNIT G CHATSWORTH, CA 91311 US 818-349-4464 / 818-349-4464 |
SDI CA480, SDI CA240 | CLINICAL CHEMISTRY ANALYZER |
| 53 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
ADIVA CENTAUR CP ANALYZER | CLINICAL ANALYZER |
| 54 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MFG LTD CHAPEL LANE SWORDS, COUNTY DUBLIN, EI 914-524-2955 / 914-524-2955 |
CT 500 | CLINICAL CHEMISTRY/ANALYZER |
| 55 | SPARTON MEDICAL SYSTEMS 22740 LUNN RD. STRONGSVILLE, OH 44149 US 800-248-9579 / 440-878-4630 226 |
MODEL 560 EXPRESS CLINICAL CHEM. ANALYZER | DISCRETE PHOTOMETRIC CHEM. ANALYZER FOR CLIN. USE |
| 56 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
SIRRUS CLINICAL CHEMISTRY ANALYZER | CHEMISTRY ANALYZER |
| 57 | STRATEC BIOMEDICAL SYSTEMS AG GEWERBESTRASSE 37 BIRKENFELD, GRAEFENHAUSEN, BW, 75217 GM 49-70-82791660 / 49-708-2791683 |
ADVIA CENTAUR CP | CLINICAL ANALYZER |
| 58 | TECAN SCHWEIZ AG 103 SEESTRASSE MAENNEDORF ZUERICH, 8708 SZ 41-44-9228888 / 41-44-9228415 |
FREEDOM EVOLYZER | CHEMICAL ANALYZER |
| 59 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
TC MATRIX ANALYZER | CHEMISTRY ANALYZER |
| 60 | THERMO FISHER SCIENTIFIC OY 2 RATASTIE VANTAA, 01620 FI / 358-932-910762 |
T60, T60I, T60I KUSTI, DPC T60I, DPC T60I KUSTI | CLINICAL CHEMISTRY ANALYZER |
| 61 | TOKYO BOEKI MEDICAL SYSTEM LTD. TACHIKAWA-NISHIKICHO BLDG., 7TH FLOOR, 1-8-7 NISHIKICHO, TACHIKAWA-SHI, TOKYO, 190-0022 JA 81-42-5507271 / 919-247-0479 |
PRESTIGE 24I, MGC 240, SIRRUS, BIOLIS 24I | CLINICAL CHEMISTRY ANALYZER |
| 62 | UV-VIS METROLAB S.A. MISIONES 1156 BERNAL OESTE, BA, 1876 AR 54-114-2529595 / 54-114-2529595 |
MULTIPLE | RANDOM ACCESS CLINICAL ANALYZERS |
| 63 | VITAL DIAGNOSTICS INC. 27 WELLINGTON ROAD LINCOLN, RI 02865 US 401-642-8400 / 401-642-8448 |
ATAC 8000 | RANDOM ACCESS CHEMISTRY SYSTEM, PHOTOMETRIC DISCRETE |
| 64 | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109 |
NONE | AUTOMATED CLINICAL CHEMISTRY ANALYZERS |
| 65 | YAMURA ELECTRIC INDUSTRY CO., LTD. 21-26-18 MURASAKINO KITAKAMI-SHI, IWATE, 024-0004 JA 81-197-682311 / 81-197-682311 |
PATHFAST | IMMUNOASSAY ANALYZER |
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