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ELECSYS CALSET PRODUCTS
 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 | JIS |
| FDA Classification Name | CALIBRATOR, PRIMARY |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1150 |
| FDA Common Generic Name | IMMUNOASSAY CALIBRATORS |
| FDA Proprietary Device Name | ELECSYS CALSET PRODUCTS |
| 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 | 05-07-01 |
| 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 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | PRIMARY CALIBRATORS |
| 2 | AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 3 | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US 317-841-0458 / 317-841-0458 |
ACS ANGIOTENSIN CONVERTING ENZYME CALIBRATOR | ACE CALIBRATOR |
| 4 | AXIS-SHIELD ASA 87 ULVENVEIEN OSLO, N-0581 NO 47-22-700600 / 47-22-042000 |
AXIS-SHIELD CDT HITACHI VERSION | AXIS-SHIELD CDT HITACHI VERSION |
| 5 | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000 |
ABBOTT AXSYM TESTOSTERONE STANDARD CALIBRATORS | STANDARD CALIBRATORS FOR USE WITH AXSYM TESTOSTERONE MEIA |
| 6 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | CALIBRATORS |
| 7 | BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000 |
MULTIPLE (QUANTIA LP(A) STANDARD) | PROTEINS CALIBRATOR |
| 8 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
SYNCHRON SYSTEMS LIPID CALIBRATOR | LIPID CALIBRATOR |
| 9 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
N LP A STANDARD SY | CALIBRATOR |
| 10 | DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311 |
MULTIPLE | CALIBRATOR, MULTIPLE-ANALYTE MIXTURE |
| 11 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS PRIMARY CALIBRATORS |
| 12 | DAIICHI PURE CHEMICALS CO., LTD. 3-1, KOYODAI 3-CHOME, RYUGASAKI-CITY IBARAKI, 301-0852 JA 011-029-7627551 / 617-768-6275 |
L DL-C REAGENT (ST TYPE), CHOLESTEST HDL REAGENT, LDL-C REAGENT | VARIOUS TYPES OF PRIMARY CALIBRATORS |
| 13 | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396 |
MULTIPLE | VARIOUS PRIMARY CALIBRATORS |
| 14 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
CALIBRATION/CONTROL SET FOR LP(A) SPQ TEST SYSTEM | CALIBRATION/CONTROL SET FOR LP(A) LIPOPROTEIN (A) |
| 15 | DIAZYME LABORATORIES 12889 GREGG COURT POWAY, CA 92064 US 858-455-4761 / 858-455-4761 |
HBA1C ENZYMATIC ASSAY | HBA1C ENZYMATIC ASSAY |
| 16 | DREW SCIENTIFIC CO. LIMITED UNIT 4 PETER GREEN WAY,FURNESS ENTERPRISE BUSINESS PARK BARROW-IN-FURNESS, CUMBRIA, LA14 2PE UK 214-210-4937 / 44-12-29 432089 |
DREW GLYCATED HEMOGLOBIN 2 LEVEL CALIBRATOR KIT | CALIBRATOR KIT |
| 17 | EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315 |
MULTIPLE | VARIOUS, SPECIFIC CONCENTRATIONS OF DIFFERENT ANALYTES, E.G. CALCIUM, MAGNESIUM, |
| 18 | EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275 |
ULTRA SENSITIVE CALIBRATOR | CRP CALIBRATOR |
| 19 | FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163 |
ARCHITECT STAT CK-MB IMMUNOASSAY CALIBRATORS | CK-MB IMMUNOASSAY CALIBRATORS |
| 20 | GENZYME CORPORATION ONE KENDALL SQUARE CAMBRIDGE, MA 02139 US 617-252-7500 / 617-768-6275 |
ULTRA N-GENEOUS HDL CHOLESTEROL CALIBRATOR | HDL CHOLESTEROL CALIBRATOR |
| 21 | GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB EISENACHER STRASSE 56 BERLIN, BERLIN, D-10823 GM 011-49-30 8263692 / 49-307-8095880 |
CALIBRATION SOLUTION FOR OSMOMAT 010/030/AUTO, KO32608 | CALIBRATOR FOR CRYOSCOPIC OSMOMETERS |
| 22 | HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845 |
CALIBRATOR, PRIMARY | CALIBRATOR, PRIMARY |
| 23 | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501 |
MULTIPLE | VARIOUS PRIMARY CALIBRATORS |
| 24 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | CALIBRATOR, PRIMARY |
| 25 | INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467 |
MULTIPLE CALIBRATORS | CALIBRATOR |
| 26 | INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061 |
BIO-CAL OPERATION CHECK KIT | BIO-CAL OPERATION CHECK KIT |
| 27 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
C-REACTIVE PROTEIN CALIBRATOR SET | C-REACTIVE PROTEIN CALIBRATOR SET |
| 28 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY LP(A) CALIBRATOR | LIPOPROTEIN(A) CALIBRATOR |
| 29 | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL WINDHAM, ME 04062 US 207-892-1300 / 800-377-9684 |
VALIDATE | VARIOUS CHEMISTRY CALIBRATOR KITS |
| 30 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
CHEMISTRY LINEARITY TEST STANDARDS | PRIMARY CALIBRATOR |
| 31 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
CHEMISTRY LINEARITY TEST STANDARDS | PRIMARY CALIBRATOR |
| 32 | MULTISCIENCES (MSI), INC. 371 11TH AVE. LACHINE, QUEBEC, H8S 3G8 CA 207-384-4839 / 207-384-4839 |
MULTIPLE | VARIOUS |
| 33 | NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425 |
CHEMISTRY LINEARITY TEST STANDARDS | PRIMARY CALIBRATOR |
| 34 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
OLYMPUS CALIBRATORS | VARIOUS TYPES OF CALIBRATORS |
| 35 | ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152 |
MULTIPLE | PROGESTIRONE |
| 36 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE) | CALIBRATORS |
| 37 | PRIMUS CORP. 4231 E. 75TH TERRACE KANSAS CITY, MO 64132 US 353-127-69800 / 816-523-7491 |
GLYCATED CALIBRATOR | GHB CALIBRATOR (LYOPHILIZED OR LIQUID) GPP CALIBRATOR (LYPHILIZED) |
| 38 | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501 |
RAICHE,;CONJUGATE STANRAD | BILIRUBIN CONJUGATE STANDARD |
| 39 | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834 |
PRECISET | PRECISET |
| 40 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
MULTIPLE | VARIOUS |
| 41 | SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US 619-258-9300 / 619-258-9300 450 |
SYSCAL | SERUM CALIBRATOR |
| 42 | SENTINEL CH. SPA VIA ROBERT KOCH, 2 MILANO, 20152 IT 39-02-3455141 / 978-927-3808 |
CRP CALIBRATOR SET,CRP CALIBRATOR HS,CRP CALIBRATOR WR | CRP CALIBRATORS |
| 43 | SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425 |
QMS/MULTIGENT VALPROIC ACID CALIBRATORS | VALPROIC ACID CALIBRATORS |
| 44 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
MAGIC LITE INTACT PTH CALIBRATOR SET | CALIBRATOR |
| 45 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | CALIBRATOR |
| 46 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LTD NORTHERN RD. CHILTON INDUSTRIAL ESTATE SUDBURY, SUFFOLK, C010 6DX UK 914-524-2955 / 914-524-2955 |
BLOOD GAS SYSTEM 600 SERIES (MULTIPLE) | BLOOD GAS SYSTEM AND 600 SERIES (VARIED) |
| 47 | STRECK 7002 SOUTH 109TH ST. OMAHA, NE 68128 US 800-843-0912 / 402-537-5313 |
MULTIPLE PRODUCTS | CALIBRATION MATERIAL FOR HEMATOLOGY INSTRUMENTS. |
| 48 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
HDL CHOLESTEROL REAGENT | DIRECT HDL CHOLESTEROL REAGENT |
| 49 | THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100 |
INFINITY AMMONIA STANDARD,CHOLESTEROL STANDARD,TRIGLYCERIDES STANDARD | CALIBRATOR |
| 50 | VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. PROVIDENCE, RI 02907 US 401-461-0180 / 401-461-0180 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 51 | VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553 |
MULTIPLE | VARIOUS CALIBRATION STANDARDS |
| 52 | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109 |
HDL-C CALIBRATOR | HDL-C CALIBRATOR |
| 53 | WAKO PURE CHEM., DIAG. RESEARCH LABS 6-1 TAKADA-CHO AMAGASAKI, HYOGO-KEN, 661-0963 JA 816-620-33741 / 650-210-9153 109 |
HDL-C CALIBRATOR | HDL-C CALIBRATOR |
| 54 | WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109 |
HDL-C CALIBRATOR | HDL-C CALIBRATOR |
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