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GENZYME DIRECT AMYLASE VERIFIER
 Request for Information Form |
 Contact Information
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| Company Name | GENZYME CORPORATION |
| Address | ONE KENDALL SQUARE |
| City, State, Zip | CAMBRIDGE, MA 02139 |
| Country | US |
| FDA Owner/Operator Phone | 617-252-7500 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | JIT |
| FDA Classification Name | CALIBRATOR, SECONDARY |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 862.1150 |
| FDA Common Generic Name | CALBRATOR FOR THE GENZYME DIRECT AMYLASE ASSAY |
| FDA Proprietary Device Name | GENZYME DIRECT AMYLASE VERIFIER |
| FDA Owner / Operator Number | 9002116 |
| FDA Owner / Operator Name | GENZYME CORPORATION |
| FDA Establishment Registration Number | 1221955 |
| FDA Registered Establishment Name | GENZYME CORPORATION |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 10-19-99 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of GENZYME CORPORATION
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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS SECONDARY CALIBRATORS |
| 2 | ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS SECONDARY CALIBRATORS |
| 3 | ALDEN MEDICAL LLC 360 COLD SPRING AVE. WEST SPRINGFIELD, MA 01089 US 413-747-9717 / 413-747-9717 |
COMPAT | CONDUCTIVITY/PH |
| 4 | ALPINE BIOMED, INC. 17800 NEWHOPE STREET FOUNTAIN VALLEY, CA 92708 US 714-839-8416 / 714-839-8426 |
PH CALIBRATION KIT | CALIBRATION BUFFER KIT FOR PH ELECTRODE OR CATHETER |
| 5 | AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000 |
ABBOTT AXSYM(R),B-TYPE NATRIURETIC PEPTIDE(BNP),MICROPARTICLE ENZYME IMMUNOASSY | AXSYM(R) BNP MICROPARTICLE ENZYME IMMUNOASSAY |
| 6 | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383 |
ULTRASENSITIVE HGH CALIBRATORS ON THE ACCESS (R) IMMUNOASSAY SYSTEM | CALIBRATOR |
| 7 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
ULTRASENSITIVE HGH CALIBRATORS ON THE ACCESS (R) IMMUNOASSAY SYSTEM | CALIBRATOR |
| 8 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | VARIOUS CALIBRATORS |
| 9 | BIOCELL LABORATORIES, INC. 2001 UNIVERSITY DR. RANCHO DOMINGUEZ, CA 90220 US 310-537-3300 / 310-537-3300 |
BIOCELL CALIBRATOR | CALIBRATOR, SINGLE |
| 10 | BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000 |
MUTIPLE (QUANTIA FERRITIN STANDARD) | PROTEINS CALIBRATOR |
| 11 | BIOMED BROKERS SRL MORENO 3302 CIUDAD DE BUENOS AIRES, C12091ABL AR 54-11-4866 4867 / 866-850-4382 |
CALIBRATING MATERIAL LABIX | CALIBRATORS FOR ISE AND/OR PH/BLOOD GAS AUTOMATED SYSTEM |
| 12 | BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423 |
TRIAGE BNP CALIBRATORS | BNP CALIBRATORS |
| 13 | BISBER CORP. SA - ILS INTERGRATED LABORATORY SOLUT RUTA 8 KM, 17.500 LOCAL 203 MONTEVIDEO, 91600 UY 598-2-5182215 / 305-779-2082 |
KLAB, KLAB ISEPACK III, KLAB ISEPACK II | CALIBRATOR, SECONDARY |
| 14 | CALIPER SYSTEMS, INC. 23 CROSBY DR. BEDFORD, MA 01730 US 781-687-9222 / 781-687-9222 |
DIRECT TIBC CALIBRATORS SET,HIGH SENSITIVITY FERRITIN CALIBRATORS | DTIBC CALIBRATORS SET,HSFERRITIN CALIBRATORS |
| 15 | CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD. SAN MARCOS, CA 92069 US 760-744-1900 / 760-744-1900 112 |
DRY QC CHEMISTRY CONTROL | QUALITY CONTROL MATERIAL |
| 16 | DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS SECONDARY CALIBRATORS |
| 17 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
MULTIPLE | VARIOUS SECONDARY CALIBRATOR |
| 18 | DAKO DENMARK A/S 42 PRODUKTIONSVEJ GLOSTRUP, DK-2600 DA 454-485-9500 / 45-88-305171 |
CYSTATIN C. CALIBRATOR | CALIBRATOR |
| 19 | DENKA SEIKEN CO., LTD (KAGAMIDA FACILITY) 1359-1, KAGAMIDA, KIGOSHI GOSEN-SHI, NIIGATA, 959-1834 JA 81-3-36699421 / 81-250-420812 |
ARCHITECT(R) INSULIN CONTROLS (LOW,MEDIUM,AND HIGH) | CALIBRATOR |
| 20 | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396 |
MULTIPLE | VARIOUS SECONDARY CALIBRATORS |
| 21 | FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163 |
ARCHITECT T-UPTAKE CALIBRATORS | ARCHITECT T-UPTAKE CALIBRATORS |
| 22 | FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829 |
ABBOTT ARCHITECT B-TYPE NATRIUETIC PEPTIDE (BNP) | BNP TEST SYSTEM |
| 23 | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501 |
MULTIPLE | VARIOUS SECONDARY CALIBRATORS |
| 24 | HORIBA ABX PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER, 34184 FR 33-467-141516 / 33-467-14 73 92 |
MULTIPLE | CALIBRATOR, SECONDARY |
| 25 | HYPHEN BIOMED 155 RUE D' ERAGNY ZAC NEUVILLE-UNIVERSITE NEUVILLE SUR OISE, 95000 FR 33-1-34406510 / 33-1-34406510 |
BIOPHEN HEPARIN & UNFRACTIONATED HEPARIN CALIBRATOR | CALIBRATOR |
| 26 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
CHEMISTRY CALIBRATOR | MULTI CALIBRATOR TWO LEVELS |
| 27 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY TOTAL IGE CALIBRATOR | TOTAL IGE CALIBRATOR |
| 28 | MISSION DIAGNOSTICS 333 FISKE ST. HOLLISTON, MA 01746 US 508-429-0450 / 508-429-0450 |
MULTIPLE | VARIOUS TYPES OF CALIBRATORS FOR BLOOD GAS & ELECTROLYTE ANALYZERS |
| 29 | NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425 |
COMPAT | CONDUCTIVITY/PH |
| 30 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
PRE-ALBUMIN CALIBRATOR | CALIBRATOR |
| 31 | ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152 |
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG CALIBRATOR | TOTAL B-HCG CALIBRATOR SYSTEM |
| 32 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KITS (MULTIPLE) | CALIBRATOR |
| 33 | QUALIGEN, INC. 2042 CORTE DEL NOGAL CARLSBAD, CA 92011 US 760-918-9165 / 760-918-9165 226 |
FAST PACK (TM) CALIBRATORS | CALIBRATORS |
| 34 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX FRUCTOSAMINE CALIBRATOR | FRUCTOSAMINE CALIBRATOR |
| 35 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX FRUCTOSAMINE CALIBRATOR | FRUCTOSAMINE CALIBRATOR |
| 36 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX FRUCTOSAMINE CALIBRATOR | FRUCTOSAMINE CALIBRATOR |
| 37 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX FRUCTOSAMINE CALIBRATOR | FRUCTOSAMINE CALIBRATOR |
| 38 | REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 BEDFORD, MA 01730 US 781-276-9000 / 781-276-9000 |
RDI FERRITIN CALIBRATOR SET | FERRITIN CALIBRATORS |
| 39 | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834 |
CALIBRATOR, SECONDARY | CALIBRATION KIT |
| 40 | ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834 |
ELECSYS TESTOSTERONE CALSET, ELECSYS FSH CALSET, ELESYS ESTRADIOL ELECSYS CEA CA | IMMUNOASSAY CALIBRATORS |
| 41 | ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 42 | SALIMETRICS LLC. 101 INNOVATION BLVD., STE. 302 STATE COLLEGE, PA 16803 US 814-234-7748 / 814-234-7748 207 |
SALIMETRICS PROGESTERONE STANDARD CALIBRATOR | PROGESTERONE STANDARD CALIBRATOR |
| 43 | SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425 |
ARCHITECT T-UPTAKE CALIBRATORS, A-F | CALIBRATOR |
| 44 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | MULTIPLE |
| 45 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540 |
MULTIPLE | MULTIPLE |
| 46 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
WR CRP CALIBRATOR | CALIBRATOR |
| 47 | THERMO FISHER SCIENTIFIC 189-199 BROWNS RD. NOBLE PARK, VICTORIA, 3174 AS / 613-979-04100 |
IRON/UIBC CALIBRATOR | CALIBRATOR |
| 48 | TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800 |
BILE ACID CALIBRATOR | CALIBRATOR |
| 49 | VERICHEM LABORATORIES, INC. 90 NARRAGANSETT AVE. PROVIDENCE, RI 02907 US 401-461-0180 / 401-461-0180 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 50 | VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553 |
MULTIPLE | VARIOUS CALIBRATORS |
| 51 | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109 |
HDL/LDL COMBO CALIBRATOR | HDL/LDL COMBO CALIBRATOR |
| 52 | WAKO PURE CHEMICAL INDUSTRIES, LTD. 2613-2 OAZA OGOHARA KOMONO-CHO MIE, 510-1222 JA 816-620-33741 / 650-210-9153 109 |
HDL/LDL COMBO CALIBRATOR | HDL/LDL COMBO CALIBRATOR |
| 53 | WATERS CORPORATION 34 MAPLE ST. MILFORD, MA 01757 US 508-478-2000 / 508-482-2545 |
MASS TRAK KIT CALIBRATOR | CALIBRATOR |
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