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DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT
 Request for Information Form |
 Contact Information
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| Company Name | DIAZYME LABORATORIES |
| Address | 12889 GREGG COURT |
| City, State, Zip | POWAY, CA 92064 |
| Country | US |
| FDA Owner/Operator Phone | 858-455-4761 |
| FDA Medical Specialty Code | HE - Hematology |
| FDA Product Code | LCP |
| FDA Classification Name | ASSAY, GLYCOSYLATED HEMOGLOBIN |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 864.7470 |
| FDA Common Generic Name | GLYCATED SERUM PROTEIN ENZYMATIC ASSAY |
| FDA Proprietary Device Name | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT |
| FDA Owner / Operator Number | 9057184 |
| FDA Owner / Operator Name | GENERAL ATOMICS |
| FDA Establishment Registration Number | 2032900 |
| FDA Registered Establishment Name | DIAZYME LABORATORIES |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 11-03-04 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of DIAZYME LABORATORIES
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 | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US 317-841-0458 / 317-841-0458 |
HEMOGLOBIN CONTROLS | VARIOUS TYPE GLYCOSYLATED HEMOGLOBIN |
| 2 | ARKRAY FACTORY INC. 1480 KOJI,KONAN-CHO, KOKA-SHI SHIGA,, 520-3306 JA 81-75-6628964 / 81-748-867298 |
SPOTCHEM II FRUCTOSAMINE | FRUCTOSAMINE/GLYCOSYLATED HEMOGLOBIN |
| 3 | ARKRAY, INC. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO, 601-8045 JA 81-75-6628964 / 81-748-867298 |
SPOTCHEM II FRUCTOSAMINE | FRUCTOSAMINE/GLYCOSYLATED HEMOGLOBIN |
| 4 | AXIS-SHIELD POC AS MARSTRANDGATA 6 OSLO, N-0566 NO 47- 22-04 20 00 / 47-22-042000 |
NYCOCARD HBA1C, NYCOCARD READER II | GLYCOSYLATED HEMOGLOBIN ASSAY |
| 5 | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430 |
METRIKA A1CNOW+ | ASSAY, GLYCOSYLATED HEMOGLOBIN |
| 6 | BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | HEMOGLOBIN ALC |
| 7 | BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383 |
MULTIPLE | HEMOGLOBIN ALC |
| 8 | BIO-RAD LABORATORIES DEESIDE UNIT 37, DRIVE B, FIRST AVE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE, CH5 2NV UK 510-724-7000 / 510-741-6263 |
GLYCOSAL HB A,C TEST | GLYCOSAL HB A,C TEST |
| 9 | BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263 |
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM | HEMOGLOBIN A1C PROGRAM |
| 10 | CANTERBURY SCIENTIFIC LTD. 14 POPE STREET CHRISTCHURCH, 8011 NZ 643-720-9625412 / 603-369-3550 |
MULTIPLE | VARIOUS MODELS OF HEMOGLOBIN CONTROLS |
| 11 | CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272 |
HBA1C | GLYCOHEMOGLOBIN REAGENT |
| 12 | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311 |
DIMENSION HA1C KIT | DIMENSION HA1C KIT |
| 13 | DIABETES TECHNOLOGIES, INC. 184 BIG STAR DR. THOMASVILLE, GA 31757 US 229-227-1245 / 229-227-1245 |
ACCUBASE A1C TEST KIT | A1 C TEST |
| 14 | DONGGUAN ZHANGMUTOU XIAN JIN KE JI DIAN ZI FACTORY PO SHAN INDUSTRIAL ESTATE ZHANGMUTOU DONGGUAN, GUANGDONG, CH 852-238-99351 / 852-238-99351 |
MULTIPLE | PRECENT HEMOGLOBIN ALC( TEST FOR THE DETECTION OF HBALC IN HUMAN WHOLE BLOOD) |
| 15 | 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 PINK KIT | GLYCOSYLATED HEMOGLOBIN ASSAY |
| 16 | DREW SCIENTIFIC, INC. 4230 SHILLING WAY DALLAS, TX 75237 US 214-210-4937 / 214-210-4937 |
DS5 ANALYZER W/DISPENSER | DS5 ANALYZER W/DISPENSER |
| 17 | EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 18 | EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US 011-49-6151726060 / 856-423-6300 315 |
GLYCOSYLATED HEMOGLOBIN | GLYCOSYLATED HEMOGLOBIN |
| 19 | EXOCELL, INC. 3508 MARKET ST., 3RD FLOOR PHILADELPHIA, PA 19104 US 215-222-5515 / 215-222-5515 |
GLYCACOR | ELISA FOR THE QUANTITATION OF HUMAN GLYCATED LOW DENSITY LIPOPROTEIN |
| 20 | FLEXSITE DIAGNOSTICS, INC. 3543 S.W. CORPORATE PKWY. PALM CITY, FL 34990 US 772-221-8893 / 772-221-8893 114 |
MULTIPLE | VARIOUS |
| 21 | GENZYME LTD. 50 GIBSON DR. WEST MALLING, KENT, ME19 6HG UK 617-252-7500 / 617-252-7500 |
MULTIPLE | VARIOUS |
| 22 | GENZYME LTD. HENRY BLAIR BLDG. LIPHOOK WAY 20/20 BUSINESS PARK ALLINGTON, MAIDSTONE, KENT, ME16 OLQ UK 617-252-7500 / 617-252-7500 |
MULTIPLE | VARIOUS |
| 23 | GLOBAL BUSINESS SUPPORT SYSTEMS, INC. 9520 CHESAPEAKE DRIVE, #601 SAN DIEGO, CA 92123 US 858-430-2800 / 858-430-2800 112 |
EZCHEK,HBA BLOOD COLLECTION KIT,SAFE AT-HOME TEST KIT MONITORING HEMOGLOBIN A | VARIOUS,BLOOD COLLECTION KITS,HEMOGLOBIN A TEST |
| 24 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLYCOHEMOGLOBIN MULTIPLE DIAGNOSIS | GLYCOHEMOGLOBIN MULTIPLE DIAGNOSIS |
| 25 | HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271 |
GLYCO-TEK AFFINITY COLUMN | COLUMN CHROMATOGRAPHY GLYCOSYLATED HEMOGLOBIN |
| 26 | HERITAGE LABS INTL., LLC 1111 WEST OLD 56 HWY. OLATHE, KS 66061 US / 913-764-1045 |
ASSAY, GLYCOSYLATED HEMOGLOBIN | APPRAISE A1C SAMPLE COLLECTION KIT |
| 27 | INTERNATIONAL BIO-ANALYTICAL INDUSTRIES, INC. 3595 NORTH DIXIE HWY., UNIT 5 BOCA RATON, FL 33431 US 561-826-0061 / 561-826-0061 |
GLYCOHEMOGLOBIN IN-VITRO DIAGNOSTIC REAGENT SET | GLYCOHEMOGLOBIN IN-VITRO DIAGNOSTIC REAGENT SET |
| 28 | JAS DIAGNOSTICS, INC. 7220 NW 58TH ST. MIAMI, FL 33166 US 305-418-2320 / 305-418-2320 |
FRUCTOSAMINE CALIBRATOR | FRUCTOSAMINE |
| 29 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY FRUCTOSAMINE REAGENT | FRUCTOSAMINE REAGENT AND CALIBRATOR |
| 30 | METRIKA, INC. 510 OAKMEAD PKWY. SUNNYVALE, CA 94085 US 408-524-2255 290 / 408-524-2255 263 |
A1CNOW | HBA1C OR A1C |
| 31 | MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425 |
DRI HEMOGLOBIN A1C ASSAY | GLYCOSYLATED HEMOGLOBIN ASSAY |
| 32 | MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425 |
DRI HEMOGLOBIN A1C ASSAY | GLYCOSYLATED HEMOGLOBIN ASSAY |
| 33 | MULTISCIENCES (MSI), INC. 371 11TH AVE. LACHINE, QUEBEC, H8S 3G8 CA 207-384-4839 / 207-384-4839 |
HEMOGLOBIN AIC | HEMOGLOBIN AIC |
| 34 | NERL DIAGNOSTICS LLC. 14 ALMEIDA AVE. EAST PROVIDENCE, RI 02914 US 412-490-8425 / 412-490-8425 |
GLYCOTRAK | GLYCOHEMOGLOBIN TEST KIT |
| 35 | OEM SYSTEMS CO. LTD. 58 MEKAWA MAKISHIMACHO UJI-SHI, 611 JA 077-420-2481 / 510-724-7000 |
BIO-RAD HEMOGLOBIN DETECTOR - MDMS | HEMOGLOBIN DETECTOR - MDMS |
| 36 | OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688 |
HEMOGLOBIN A1C TEST SYSTEM | HEMOGLOBIN A1C TEST SYSTEM |
| 37 | ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768 |
VITROS CHEMISTRY PRODUCTS %A1C REAGENT KIT | GLYCOCHEMOGLOBIN ASSAY |
| 38 | POINTE SCIENTIFIC, INC. 5449 RESEARCH DRIVE CANTON, MI 48188 US 734-487-8300 / 734-487-8310 |
GLYCOHEMOGLOBIN | |
| 39 | POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363 |
POLYMEDCO HBA1C TEST | HEMOGLOBIN A1C |
| 40 | PRIMUS CORP. 4231 E. 75TH TERRACE KANSAS CITY, MO 64132 US 353-127-69800 / 816-523-7491 |
LC AFFINITY ASSAY | CLC 330 GLYCATED HEMOGLOBIN ANALYZER |
| 41 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX HEMOGLOBIN AIC | HEMOGLOBIN AIC |
| 42 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX HAEMOGLOBIN AIC | HAEMOGLOBIN AIC |
| 43 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX HAEMOGLOBIN AIC | HAEMOGLOBIN AIC |
| 44 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX HAEMOGLOBIN A/C | HAEMOGLOBIN A/C |
| 45 | SANDARE INTL., INC. 910 K.C.K. WAY CEDAR HILL, TX 75104 US 972-293-7440 / 972-293-7440 |
NO PROPRIETARY NAME LISTED | NO COMMON NAME LISTED |
| 46 | SANMINA-SCI AB SVEDJEVAGEN 12 SJALEVAD, SE-89123 SW / 46-660-266645 |
NYCOCARD READER II | NYCOCARD READER II |
| 47 | SEBIA PARC TECHNOLOGIQUE LEONARD DE VINCI EVRY, 91008 FR 33-169-898080 / 770-446-3707 3704 |
HYDRAGEL 15 HB A1C KIT | ELECTROPHORESIS FOR ASSAY OF GLYCOSYLATED HEMOGLOBIN |
| 48 | SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425 |
MULTIGENT HEMOGLOBIN ASSAY | GLYCOSYLATED HEMOGLOBIN ASSAY |
| 49 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | HEMOGLOBIN A1C ASSAY |
| 50 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
STANBIO GLYCOHEMOGLOBIN TEST SET | QUANTITATIVE COLORIMETRIC DETERMINATION OF GLYCOHEMOGLOBIN IN WHOLE BLOOD |
| 51 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
HEMOGLOBIN A1C REGENTS, CALIBRATOR, CONTROLS | HEMOGLOBIN A1C REAGENT SET |
| 52 | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909 |
A1C 2.2 PLUS GLYCOHEMOGLOBIN ANALYZER, G7 AUTOMATED HPLC ANALYZER, HB A1C VARIAN | GLYCOSYLATED HEMOGLOBIN, HEMOGLOBIN A1C |
| 53 | TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909 |
A1C2.2 PLUS GLYCOHEMOGLOBIN ANALYZER, G7 AUTOMATED HPLC ANALYZER, HB A1C VARIANT | GLYCOSYLATED HOMOGLOBIN ASSAY |
| 54 | TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909 |
DIAMAT GLYCOSYLATED HEMOGLOBIN SYSTEM | AUTOMATED GLYCOSYLATED HEMOGLOBIN SYSTEM |
| 55 | VITAL DIAGNOSTICS INC. 1075 WEST LAMBERT ROAD, UNIT D BREA, CA 92821 US 401-642-8400 / 714-672-3553 |
HEMOGLOBIN A1C REAGENT KIT | HEMOGLOBIN A1C REAGENT KIT |
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