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OMNILINK 3.4
 Request for Information Form |
 Contact Information
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| Company Name | ROCHE DIAGNOSTICS GMBH |
| Address | NONNENWALD 2 |
| City, State, Zip | PENZBERG, |
| Country | GM |
| FDA Owner/Operator Phone | 49-621-7670 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | JQP |
| FDA Classification Name | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 862.2100 |
| FDA Common Generic Name | DATA PROCESSOR |
| FDA Proprietary Device Name | OMNILINK 3.4 |
| FDA Owner / Operator Number | 9036646 |
| FDA Owner / Operator Name | ROCHE DIAGNOSTICS GMBH MANNHEIM |
| FDA Establishment Registration Number | 9610529 |
| FDA Registered Establishment Name | ROCHE DIAGNOSTICS GMBH |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 04-25-06 |
| 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 GMBH
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 |
WORKCELL SYSTEM | CALCULATOR/DATA PROCESSOR |
| 2 | ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471 |
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | CENTRAL DATA STATION |
| 3 | AMERICAN MEDICAL DIAGNOSTICS, INC. 4031 UNIVERSITY DRIVE SUITE 200 FAIRFAX, VA 22030 US 703-938-6500 / 703-938-6500 1222 |
DX AUTHOR, MEDEXPERTISE | DISTRIBUTED, COMPUTER-BASED NETWORK FOR COLLABORATIVE DIAGNOSTICS BETWEEN MEDICA |
| 4 | ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168 |
GLUCOBALANCE (TM) DATA MANAGEMENT SOFTWARE | DIABETES DATA MANAGEMENT SOFTWARE |
| 5 | B & C BIOTECH 24910 WASHINGTON AVE SUITE 204 MURRIETA, CA 92562 US 951-894-6650 / 951-894-6650 |
FREE AND BIOAVAILABLE STEROID CALCULATOR | SMART HORMONE MANAGEMENT |
| 6 | BAXA CORP. 14445 GRASSLANDS DR. ENGLEWOOD, CO 80112 US 303-617-2181 / 303-617-2242 |
TPN-PC PLUS | TPN CALCULATING SOFTWARE |
| 7 | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. BREA, CA 92821 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | DATALINK DATA MGMT. SYSTEM |
| 8 | BIO-LOGIC SYSTEMS CORP. ONE BIOLOGIC PLAZA MUNDELEIN, IL 60060 US 800-255-3901 / 847-949-5200 267 |
MULTIPLE | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| 9 | BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US 33-478-872063 / 314-731-8594 |
OBSERVA | CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE |
| 10 | BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. REDMOND, WA 98052 US 425-881-8300 / 425-498-1709 |
MICROPLATE ASSAY MANAGEMENT SOFTWARE (MAS) | MICROPLATE ASSAY MANAGEMENT SOFTWARE (MAS) |
| 11 | CALDWELL, JUSTISS & CO., INC. 622 WEST SYCAMORE FAYETTEVILLE, AR 72702 US / 479-442-7553 |
SKYNDEX ELECTRONIC BODY FAT CALCULATOR | SKINFOLD CALIPER |
| 12 | CARDINAL HEALTH 303, INC. 12120 SUNSET HILLS ROAD RESTON, VA 20190 US 858-458-7830 / 858-458-7830 |
SPECIMEN COLLECTION VERIFICATION SYSTEM | SPECIMEN COLLECTION VERIFICATION SYSTEM |
| 13 | CARDIOCOM LLC 7980 CENTURY BLVD. CHANHASSEN, MN 55317 US 888-243-8881 / 888-243-8881 |
CARESTAR | DATAPROCESSING MODULE |
| 14 | CERNER CORP. 2800 ROCKCREEK PKWY. KANSAS CITY, MO 64117 US 816-201-1368 / 816-201-1368 |
CERNER MILLENIUM PATHNET GENERAL LABORATORY | LABORATORY INFORMATION SYSTEM |
| 15 | CISCO SYSTEMS, INC. 170 WEST TASMAN SAN JOSE, CA 95134 US 408-526-4000 / 408-527-8397 |
CISCO WIRELESS VOIP PHONE | LABORATORY DATA INFORMATION SYSTEM |
| 16 | DATA INNOVATIONS, INC. 120 KIMBALL AVE., SUITE 100 SOUTH BURLINTON, VT 05403 US 802-658-2850 / 802-264-3420 1420 |
INSTRUMENT MANAGER | LABORATORY INSTRUMENT INTERFACE |
| 17 | DE NOVO SOFTWARE 3250 WILSHIRE BLVD., SUITE 803 LOS ANGELES, CA 90010 US 213-384-7000 / 213-384-7000 |
FCS EXPRESS | FLOW CYTOMETRY DATA ANALYSIS SOFTWARE |
| 18 | DRAEGER MEDICAL SYSTEMS, INC. 6 TECH DRIVE ANDOVER, MA 01810 US 215-660-2078 / 215-660-2078 |
MULTIPLE | CALCULATOR,DATA PROCESSING MODULE,FOR CLINICAL USE |
| 19 | DRAEGER MEDICAL SYSTEMS, INC. 16 ELECTRONICS AVE. DANVERS, MA 01923 US 215-660-2078 / 215-660-2078 |
MULTIPLE | CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE |
| 20 | ESTENDA SOLUTIONS, INC. 625 WEST RIDGE PIKE, STE. D105 CONSHOHOCKEN, PA 19428 US 610-834-2908 / 610-834-2908 |
PHOENIXCARE | BARIATRIC SURGERY DATA MANAGEMENT TOOL |
| 21 | GE HEALTHCARE INTEGRATED IT SOLUTIONS 3100 STEELES AVE EAST SUITE 900 MARKHAM, ONTARIO, L3R 8T3 CA 847-277-5002 / 847-277-5002 |
MULTIPLE | LABORATORY INFORMATION SYSTEMS |
| 22 | GLOBAL CARE QUEST 65 ENTERPRISE, SUITE 350 ALISO VIEJO, CA 92656 US 949-326-3266 / 949-326-3266 |
KIS | MEDICAL DASHBOARD |
| 23 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | LABORATORY INFORMATION SYSTEM |
| 24 | HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208 |
HEMALINK | DATA MANAGEMENT SYSTEM |
| 25 | ILEX MEDICAL LTD. 21, HAMELACHA ST. AFEQ INDUSTRIAL PARK ROSH-HA'AYIN, 48091 IS 972-3-9385501 / 972-3-9385523 |
EL@B, ELAB, DATAWIZARD | LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS) SOFWARE |
| 26 | INPECO S.P.A. 14/B VIALE EUROPA BORGONE, 10050 IT 39-02-2138438 / 39-02-36595005 |
ABBOTT/DADEBEHRING | LABORATORY AUTOMATED SYSTEM |
| 27 | INTEGRAMED AMERICA, INC. TWO MANHATTANVILLE RD. PURCHASE, NY 10577 US 914-253-8000 / 914-253-8000 |
ARTWORKS STATS | ARTWORKS STATS |
| 28 | IRIS DIAGNOSTICS 9172 ETON AVE. CHATSWORTH, CA 91311 US 818-709-1244 7129 / 818-709-1244 7129 |
ICONNECT CONNECTIVITY MODULE | SERIAL DATA PROTOCOL CONVERTER |
| 29 | LEXICOR MEDICAL TECHNOLOGY, INC. 2840 WILDERNESS PL, SUITE E BOULDER, CO 80301 US 706-447-1074 / 303-443-9944 |
DATALEX LABORATORY INFORMATION MGMT. SYSTEM SOFTWARE | LABORATORY INFORMATION MGMT. SYSTEM SOFTWARE |
| 30 | MEDICAL AUTOMATION SYSTEMS, INC. 2000 HOLIDAY DR., STE. 500 CHARLOTTESVILLE, VA 22901 US 888-971-7953 / 888-971-7953 |
RALS | DATA MANAGEMENT SYSTEMS |
| 31 | MEDICAL DECISIONS NETWORK 2000 HOLIDAY DR., SUITE 200 CHARLOTTESVILLE, VA 22901 US 434-971-7953 / 434-971-7953 |
MDN-CGS, ICUTRACKER, MDN-NBI | MDN-CGS INSULIN DOSING CALCULATOR,ICUTRACKER,MDN-NBI NATIONAL BENCHMARKING INITI |
| 32 | MISYS HEALTHCARE SYSTEMS 250 S. WILLIAMS BLVD. TUCSON, AZ 85711 US 800-847-8102 / 520-570-2252 |
MISYS COMMERCIAL LABORATORY | LABORATORY INFORMATION SYSTEM (LIS) |
| 33 | MISYS HEALTHCARE SYSTEMS 250 S. WILLIAMS BLVD TUCSON, AZ 85711 US 800-847-8102 / 520-570-2252 |
FLEXILAB W/MICROBIOLOGY & COPATH PLUS ANATOMIC PUTHOLOGY MODULES | LABORATORY INFORMATION SYSTEM (LIS) |
| 34 | MONOGEN, INC. 3630 BUR WOOD DR. WAUKEGAN, IL 60085 US 847-573-6700 / 847-758-4234 |
MONOPREP SAVANT DATA MANAGEMENT SYSTEM AND ACCESSORIES | CALCULATOR DATA PROCESSOR MODULE FOR CLINICAL USE |
| 35 | MONTEREY MEDICAL SOLUTIONS, INC. 26265 TORO RD SALINAS, CA 93908 US 831-998-0534 / 214-952-3018 |
TPN MEDSOFT | TPN CALCULATING SOFTWARE |
| 36 | NEOTERIC TECHNOLOGY LTD 206-1099 WEST 8TH AVE. VANCOUVER, BRITISH COLUMBIA, V6H 1C3 CA 604-742-3820 / 604-742-3820 |
MULTIPLE | AUTOCARD, AUTOTRACK, AUTOFILE, PATHREQUEST, PATHCOLLECT |
| 37 | NORMAND INFORMATIQUE 57 GRAND' PLACE ARRAS, 62028 FR 333-21-217575 / 333-21-217575 |
REMISOL2000 ADVANCE | DATAMANAGEMENT SYSTEM |
| 38 | NUCLETRON B.V. 3900 AX VEENENDAAL P.O. BOX 930 TH VEENENDAAL, 3905 NL 011-313-18557133 / 410-312-4100 |
ONCENTRA EPF | ELECTRONIC PATIENT FOLDER |
| 39 | OLYMPUS DIAGNOSTICA LAB AUTOMATION GMBH NYMPHENBURGERSTR. 20A MUNCHEN, 80335 GM 040-237-73469 / 484-896-5688 |
OLA 2500 OLYMPUS LAB AUTOMATION SYSTEM | LAB AUTOMATION SYSTEM |
| 40 | OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH BOTZINGERSTR. 31 FREIBURG, D-79111 GM 040-237-73469 / 484-896-5688 |
OLA 2500 OLYMPUS LAB AUTOMATION SYSTEM | LAB AUTOMATION SYSTEM |
| 41 | OLYMPUS DIAGNOSTICA LAB-AUTOMATION GMBH LAITERMATTEN 5 UMKIRCH, D-79224 GM 040-237-73469 / 484-896-5688 |
OLA 2500 OLYMPUS LAB AUTOMATION SYSTEM | LAB AUTOMATION SYSTEM |
| 42 | OPTI MEDICAL SYSTEMS INC. 235 HEMBREE PARK DRIVE ROSWELL, GA 30076 US 207-556-8155 / 770-510-4444 4466 |
DATA TROL | CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE |
| 43 | PATIENTKEEPER, INC. 20 GUEST ST, SUITE 500 BRIGHTON, MA 02135 US 617-987-0343 / 888-933-2443 347 |
LABKEEPER | LABKEEPER |
| 44 | PDS HEALTH, INC. 112 INTRACOASTAL POINTE DRIVE JUPITER, FL 33477 US 800-440-2417 / 305-446-4141 |
TELEMONITOR,MDMONITOR | CENTRAL DATA TRANSFER STATION,DIABETES DATA MANAGEMENT SOFTWARE |
| 45 | PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278 |
MULTIPLE | DATA PROCESSING MODULE, FOR CLINICAL USE |
| 46 | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. ANDOVER, MA 01810 US 425-487-7000 / 978-659-4252 |
PATIENT MONITOR | |
| 47 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 BOEBLINGEN, D 71034 GM 425-487-7000 / 978-659-4252 |
MULTIPLE | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| 48 | POINTONE SYSTEMS, LLC 10437 INNOVATION DR. WAUWATOSA, WI 53226 US 414-771-1802 / 414-771-1802 200 |
POINTONE CLINICAL SYSTEM, PCS | HEALTH INFORMATION SYSTEM |
| 49 | QUADRAMED CORPORATION 12110 SUNSET HILLS RD. RESTON, VA 20190 US 703-742-5358 / 703-904-5611 |
AFFINITY LABORATORY | LABORATORY INFORMATION SYSTEM (LIS) |
| 50 | QUADRAMED INTERNATIONAL PTY LIMITED 181 MILLER ST., LEVEL 2 SUITE 201 NORTH SYDNEY, NSW, 2059 AS 703-742-5358 / 703-742-5358 |
AFFINITY LABORATORY | LABORATORY INFORMATION SYSTEM (LIS) |
| 51 | RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS MODELS OF CALCULATORS/PROCESSING MODULES |
| 52 | SASCO, INC. 10069 CAMBRIDGE BLUE AVENUE LAS VEGAS, NV 89147 US 702-233-8104 / 702-233-8104 |
COMPUTER | |
| 53 | SCC SOFT COMPUTER 5400 TECH DATA DR. CLEARWATER, FL 33760 US 727-789-0100 / 727-789-0100 4629 |
SOFTLAB, SOFTMIC, SOFTPATH | LABORATORY INFORMATION SYSTEM |
| 54 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| 55 | SMITH AND NEPHEW MEDICAL LTD. 101 HESSLE RD. HULL, HU3 2BN UK 440-148-2225181 / 440-148-2225181 |
VISITRAK DIGITAL | WOUND MEASUREMENT DEVICE |
| 56 | STANDING STONE, INC. 49 RICHMONDVILLE AVE WESTPORT, CT 06880 US 203-227-8710 / 203-227-8710 200 |
COAGCLINIC | COAGCLINIC |
| 57 | SYSMEX CORPORATION 4-4-4 TAKATSUKADAI NISHI-KU KOBE, 651-2271 JA 817-826-50500 / 847-996-4512 |
DATA PROCESSING SYSTEMS | DPS |
| 58 | TECAN AUSTRIA GMBH 1A UNTERSBERGSTRASSE GROEDIG SALZBURG, 5082 AU 41-44-9228888 / 43-62-468933198 |
MAGELLAN | CALCULATOR |
| 59 | TECHNIDATA SAS 387, AVENUE JEAN KUNTZMANN MONTBONNOT ST. MARTIN, 38330 FR 334-760-41300 / 334-760-41300 |
TD-MICRO,TD-WEB,TDCONCENTRATOR,TD-SYNERGY,TD-MIDDLEWARE,TDWORKSTATION,TDHISTO/CY | TD-MICRO,TD-WEB,TDC,TD-SYNERGY,TD-MIDDLEWARE,TDW,TDHC; |
| 60 | THERMO FISHER SCIENTIFIC INC. 171 INDUSTRY DR. PITTSBURGH, PA 15275 US / 269-544-5614 |
SHANDON CHECKMATE | DATA VERIFICATION SOFTWARE |
| 61 | TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909 |
TOSOH DMS | CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE |
| 62 | VERTEX INTERNATIONAL, INC. 7429 FORT MASON DR. ROANOKE, VA 24018 US 540-989-6945 / 540-989-6945 |
CLINICAL LABORATORY QC RANDOMIZER | COMPUTER DATABASE SOFTWARE |
| 63 | WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111 |
SPECIMEN GATE SYSTEMS | LABORATORY INFORMATION MANAGEMENT SYSTEMS |
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