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DBEST ALBUMINE URINE TEST KIT
 Request for Information Form |
 Contact Information
|
| Company Name | AMERITEK USA, INC. |
| Address | 125 130 ST. SE,
#200 |
| City, State, Zip | EVERETT, WA 98208 |
| Country | US |
| FDA Owner/Operator Phone | 425-379-2580 |
| FDA Medical Specialty Code | CH - Clinical Chemistry |
| FDA Product Code | JIR |
| FDA Classification Name | INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 862.1645 |
| FDA Common Generic Name | ALBUMIN URINE TEST KIT |
| FDA Proprietary Device Name | DBEST ALBUMINE URINE TEST KIT |
| FDA Owner / Operator Number | 9002732 |
| FDA Owner / Operator Name | AMERITEK USA, INC. |
| FDA Establishment Registration Number | 3025672 |
| FDA Registered Establishment Name | AMERITEK USA, INC. |
| FDA Operation Code(s) |
MM - Manufacturer |
| FDA Listing Date | 09-04-00 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of AMERITEK USA, INC.
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 | ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828 |
ACON URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 2 | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828 |
ACON URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 3 | ARJ MEDICAL, INC. 209 STATE STREET OLDSMAR, FL 34677 US 813-855-1557 / 813-855-1557 |
URITEST 10 URINALYSIS REAGENT STRIPS | URINALYSIS REAGENT STRIPS |
| 4 | ARKRAY FACTORY USA, INC. 5182 WEST 76TH ST. MINNEAPOLIS, MN 55439 US 81-75-6628964 / 952-646-3168 |
DIASCREEN REAGENT STRIPS FOR URINALYSIS | URINE TEST STRIPS |
| 5 | BAYER HEALTHCARE LLC 555 WHITE PLAINS RD. 5TH FLOOR TARRYTOWN, NY 10591 US 914-524-2955 / 574-262-6372 |
CMBSTIX | VARIOUS |
| 6 | BAYER HEALTHCARE, LLC 430 SOUTH BEIGER ST. MISHAWAKA, IN 46544 US 914-524-2955 / 574-256-3430 |
CMBSTIX | VARIOUS |
| 7 | BECKMAN COULTER, INC. 1050 PAGE MILL RD., BLDG. 2-B PALO ALTO, CA 94303 US 714-871-4848 / 714-993-5321 8383 |
ICON MICROALBUMIN | MICROALBUMIN |
| 8 | BEIJING CONDOR-TECO MED. TECHNOLOGY NO. 49 YONGAN STREET CHANGPING BEIJING, CH 011-861-089715701 / 714-693-7788 |
URINE PROTEIN/GLUCOSE TEST STRIPS | URINE PROTEIN/GLUCOSE TEST STRIPS |
| 9 | BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412 |
BIOTECHNOSTIX | URINARY PROTEIN OR ALBUMIN (NONQUANTITATIVE) TEST SYSTEM. |
| 10 | DFI CO., LTD. 542-1 DAMAN-RI, JINRYE-MYUN GIMHAE-CITY, GYUNG-NAM, KS 82-55-3461882 / 909-980-9933 |
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | URINARY PORTEIN OR ALBUMIN (NONQUANTITATIVE) TEST SYSTEM |
| 11 | DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396 |
IMMUNODIP | IMMUNODIP |
| 12 | DIRUI INDUSTRIAL CO., LTD. 95 YUNHE ST., NEW & HIGH TECH DEVELOPMENT ZONE CHANGCHUN, 130012 CH 86-431-5100409 / 516-482-9001 |
DIRUI | MULTIPLE REAGENT STRIPS |
| 13 | E K IND., INC. 1403 HERKLMER ST. JOLIET, IL 60432 US 815-723-4000 / 815-723-4000 |
SULFOSAILCYLIC ACID, 3% | SULFOSAILCYLIC ACID, 3% |
| 14 | EGYPTIAN CO. FOR BIOTECHNOLOGY BLDG 19A, BLOCK 20008, STREET 163 OBOUR CITY, CAIRO, EG 2-02-6651848 / 2-02-6651848 |
SPECTRUM DIAGNOSTICS URIN. PROT/ALBUM TEST SYS | URINARY PROTEIN OR ALBUMIN TEST SYSTEM |
| 15 | EXOCELL, INC. 3508 MARKET ST., 3RD FLOOR PHILADELPHIA, PA 19104 US 215-222-5515 / 215-222-5515 |
DIALBUMIN | ELISA FOR THE QUANTITATION OF HUMAN ALBUMIN (FORMATTED FOR ACC-U-DIAL) |
| 16 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED URINE REAGENT STRIPS | URINE REAGENT STRIPS |
| 17 | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068 |
K-ASSAY MICROALBUMIN IMMUNOTURBIDIMETRIC ASSAY | MICROALBUMIN IMMUNOTURBIDIMETRIC ASSAY |
| 18 | KIMBALL ELECTRONICS (WALES) LIMITED WESTERN AVENUE BRIDGEND INDUSTRIAL ESTATE BRIDGEND, WALES, CF31 3TY UK 812-634-4172 / 44-163-5566448 |
COMBISTIX | VARIOUS URINARY PROTEIN TEST SYSTEMS |
| 19 | ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955 |
ORGENTEC MICROALBUMIN ASSAY | MICROALBUMIN ASSAY |
| 20 | POCHEMCO, INC. 724 MAIN HOLYOKE, MA 01040 US 413-536-2900 / 413-536-2900 |
SULFOSALICYCLIC ACID 3%, 5% & 20% | SULFOSALICYCLIC ACID |
| 21 | RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413 |
RANDOX URINARY PROTEIN | URINARY PROTEIN |
| 22 | RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413 |
RANDOX URINARY PROTEIN | URINARY PROTEIN |
| 23 | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413 |
RANDOX URINARY PROTEIN | URINARY PROTEIN |
| 24 | RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413 |
RANDOX URINARY PROTEIN | URINARY PROTEIN |
| 25 | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834 |
CHEMSTRIP MICRAL | MICROALBUMINARA NON-QUANTIFIED URINARY TEST |
| 26 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 3400 MIDDLEBURY ST. ELKHART, IN 46514 US 914-524-2955 / 914-524-2955 |
CMBSTIX | VARIOUS |
| 27 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
DOUBLE ANTIBODY ALBUMIN | IMMUNOASSAY FOR DETECTION & QUANT. OF MICROALBUMINURIA |
| 28 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955 |
DOUBLE ANTIBODY ALBUMIN | IMMUNOASSAY FOR DETECTION & QUANT. OF MICROALBUMINURIA |
| 29 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955 |
MULTIPLE | TOTAL PROTEIN (URINE) ASSAY |
| 30 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955 |
DOUBLE ANTIBODY ALBUMIN | IMMUNOASSAY FOR THE DETECTION AND QUANTITATION OF MICROALBUNINURIA |
| 31 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
URI-QUICK 10SG | URINARY PROTEIN |
| 32 | SYNERMED INTL., INC. 17408 TILLER COURT, STE. 1900 WESTFIELD, IN 46074 US 317-896-1565 / 317-896-1565 |
SYNERMED ALBUMIN REAGENT KIT | ALBUMIN TEST SYSTEM |
| 33 | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788 |
URINE REAGENT STRIPS | URINE REAGENT STRIPS |
| 34 | TEXAS IMMUNOLOGY, INC. 12524 FM 3226 TYLER, TX 75707 US 903-566-6696 / 903-566-6696 |
TARGET MICRO ALBUMIN TEST | URINARY PROTEIN OR ALBUMIN (NON-QUANTITATIVE) TEST SYSTEM |
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