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VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE CALIBRATORS
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| Company Name | ORTHO-CLINICAL DIAGNOSTICS |
| Address | FOREST FARM ESTATE WHITCHURCH |
| City, State, Zip | CARDIFF, |
| Country | UK |
| FDA Owner/Operator Phone | 585-453-4469 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | JIX |
| FDA Classification Name | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1150 |
| FDA Common Generic Name | TESTOSTERONE CALIBRATORS |
| FDA Proprietary Device Name | VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE CALIBRATORS |
| FDA Owner / Operator Number | 9011934 |
| FDA Owner / Operator Name | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| FDA Establishment Registration Number | 9680658 |
| FDA Registered Establishment Name | ORTHO-CLINICAL DIAGNOSTICS |
| FDA Operation Code(s) |
MM - Manufacturer MS - Specification Developer |
| FDA Listing Date | 12-01-05 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of ORTHO-CLINICAL DIAGNOSTICS
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 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471 |
DOA MULTICONSTITUENT CALIBRATOR | MULTI-ANALYTE CALIBRATOR OR STANDARD |
| 2 | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US 317-841-0458 / 317-841-0458 |
ACS CHOLESTEROL/TRIGLYCERIDE LINEAR CALIBRATOR | CHOLESTEROL/TRIGLYCERIDE LIQUID LINEAR CALIBRATOR |
| 3 | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000 |
AXSYM ANTI-CCP CALIBRATOR KIT | CALIBRATORS |
| 4 | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430 |
NO PROPRIETARY NAME LISTED | CALIBRATOR |
| 5 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | CALIBRATORS |
| 6 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | CALIBRATORS |
| 7 | BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. RANCHO DOMINGUEZ, CA 90220 US 310-537-3300 / 310-537-3300 |
BIOCELL CALIBRATOR | CALIBRATOR, MULTIANALYTE |
| 8 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
CALIBRATORS | MEDICAL REAGENT CALIBRATORS |
| 9 | CATACHEM, INC. 70 HAWLEY AVE. BRIDGEPORT, CT 06606 US 203-335-9277 / 203-335-9277 |
CATACAL III | CALIBRATOR |
| 10 | CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD. SAN MARCOS, CA 92069 US 760-744-1900 / 760-744-1900 112 |
OLYMPUS URINE CALIBRATOR | QUALITY CONTROL MATERIAL |
| 11 | DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311 |
MULTIPLE | CALIBRATOR |
| 12 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS MULTI-ANALYTE MIXTURE CALIBRATORS |
| 13 | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396 |
DC-LINEATE CALG. NO.SE-091 | DC-LINEATE CALG. NO.SE-091 |
| 14 | DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851 |
STAR - UNICALIBRATOR, UNICALIBRATOR | CALIBRATORS FOR ASSAY OF HAEMOSTATSIS PARAMETERS |
| 15 | DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851 |
STAR - UNICALIBRATOR, UNICALIBRATOR | CALIBRATORS FOR ASSAY OF HAEMOSTATSIS PARAMETERS |
| 16 | DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820 |
CALIBRATOR, MULTI-ANALYTE MIXTURE | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| 17 | EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. EXTON, PA 19341 US 617-252-7500 / 617-768-6275 |
BIOTROL REFERENCE AND BIOTROL HIGH REFERENCE | CALIBRATOR |
| 18 | HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845 |
CALIBRATOR, MULTI-ANALYTE MIXTURE | CALIBRATOR, MULTI-ANALYTE MIXTURE |
| 19 | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501 |
MULTIPLE | VARIOUS MULTI-ANALYTE MIXTURE CALIBRATORS |
| 20 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | MULTI-ANALYTE CALIBRATOR |
| 21 | HYPHEN BIOMED 155 RUE D' ERAGNY ZAC NEUVILLE-UNIVERSITE NEUVILLE SUR OISE, 95000 FR 33-1-34406510 / 33-1-34406510 |
BIOPHEN PLASMA CALIBRATOR | CALIBRATOR |
| 22 | INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467 |
MULTIPLE | VARIOUS |
| 23 | INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061 |
CHEMISTRY CALIBRATOR | CHEMISTRY CALIBRATOR |
| 24 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
MULTI-ANALYTE CALIBRATOR | MULTI-ANALYTE CALIBRATOR |
| 25 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY MICROALBUMIN MULTI-CALIBRATOR SET | MICROALBUMIN CALIBRATORS |
| 26 | KING DIAGNOSTICS, INC. 980 PARK CTR. DR. SUITE F,G VISTA, CA 92081 US 760-597-1182 / 760-597-1182 |
CALIBRATOR | CALIBRATOR |
| 27 | MAINE STANDARDS CO. 765 ROOSEVELT TRAIL WINDHAM, ME 04062 US 207-892-1300 / 800-377-9684 |
VALIDATE | VARIOUS MULTI-ANALYTE CHEMISTRY CALIBRATORS |
| 28 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
MULTIPLE | MULTI-ANALYTE CALIBRATOR FOR TDM ASSAYS |
| 29 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
MULTIPLE | MULTI-ANALYTE CALIBRATOR FOR TDM ASSAYS |
| 30 | MULTISCIENCES (MSI), INC. 371 11TH AVE. LACHINE, QUEBEC, H8S 3G8 CA 207-384-4839 / 207-384-4839 |
CALIBRATOR SERUM | CALIBRATOR SERUM |
| 31 | NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425 |
MULTIPLE | VARIOUS MULTI-ANALYTE MIXTURE CALIBRATORS |
| 32 | NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068 |
MULTIPLE | VARIOUS CALIBRATORS FOR ITAS |
| 33 | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211 |
MULTIPLE | VARIOUS |
| 34 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
OLYMPUS MULTI-CALIBRATOR | CALIBRATOR MATERIAL |
| 35 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE) | CALIBRATORS |
| 36 | PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE NATICK, MA 01760 US 508-655-8310 / 508-655-8310 |
CALIBRATOR MULTI-ANALYTE MIXTURE | CALIBRATOR MULTI-ANALYTE MIXTURE |
| 37 | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310 |
CHEMISTRY CALIBRATOR | |
| 38 | RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ, DK-2700 DA 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS TYPES OF CALIBRATION SOLUTIONS |
| 39 | RADIOMETER MEDICAL APS INDUSTRIPARKEN 39-43 BALLERUP, DK-2750 DA 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS TYPES OF CALIBRATION SOLUTIONS |
| 40 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX APOLIPOPROTEIN CALIBRATOR, MULTIPLE | APOLIPOPROTEIN CALIBRATOR, CALIBRATION SERUM |
| 41 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX APOUPOPROTEIN CALIBRATOR, MULTIPLE | APOUPOPROTEIN CALIBRATOR, CALIBRATION SERUM |
| 42 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RADOX APOLIPOPROTEIN CALIBRATOR OR MULTIPLE | APOLIPOPROTEIN CALIBRATOR & CALIBRATION SERUM |
| 43 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
MULTIPLE | CALIBRATION SERUM |
| 44 | REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501 |
HDL-CHOLESTEROL CALIBRATOR | HDL-CHOLESTEROL CALIBRATOR |
| 45 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
CALIBRATOR, MULTI-ANALYTE MIXTURE | CALIBRATORS FOR MULTIPLE ANALYTES |
| 46 | SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US 45-38-273827 / 45-38-273617 |
MULTIPLE | VARIOUS MODELS OF BLOOD ANALYZERS |
| 47 | SENTINEL CH. SPA VIA ROBERT KOCH, 2 MILANO, 20152 IT 39-02-3455141 / 978-927-3808 |
CLIN CHEM CAL,PLASMAPROTEINS CAL 3X | CLINICAL CHEMISTRY CALIBRATOR, CALIBRATOR,MULTY-ANALYTE MIXTURE |
| 48 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
CK-MB CALIBRATOR | CALIBRATOR |
| 49 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955 |
CLINI-TEK ATLAS CALIBRATOR SOLUTION | CALIBRATOR |
| 50 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | MULTIPLE |
| 51 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
ISE CALIBRATOR 1; ISE CALIBRATOR 2 | CALIBRATOR |
| 52 | SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565 |
SYNERMED IR CAL I AND SYNERMED IR CAL II | CLINICAL CHEMISTRY CALIBRATOR |
| 53 | THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100 |
DATA-CAL, CALIBRATOR | CALIBRATOR |
| 54 | THERMO FISHER SCIENTIFIC INC. 166 CUMMINGS CENTER BEVERLY, MA 01915 US / 978-232-6000 6095 |
MULTIPLE | VARIOUS CALIBRATION STANDARDS FOR VARIOUS IVD ANALYZERS |
| 55 | VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553 |
MULTIPLE | VARIOUS CALIBRATORS AND CALIBRATION STANDARDS |
| 56 | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109 |
VARIOUS CALIBRATORS | CALIBRATORS |
| 57 | WAKO PURE CHEM., DIAG. RESEARCH LABS 6-1 TAKADA-CHO AMAGASAKI, HYOGO-KEN, 661-0963 JA 816-620-33741 / 650-210-9153 109 |
VARIOUS CALIBRATOR | CALIBRATORS |
| 58 | WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109 |
VARIOUS CALIBRATORS | CALIBRATORS |
| 59 | WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982 |
CALIBRADOR A PLUS | CALIBRATOR-FOR USE IN A TEST SYSTEM TO ESTABLISH POINTS OF REFERENCE THAT ARE |
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