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DBEST STREP A 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 | MI - Microbiology |
| FDA Product Code | GTY |
| FDA Classification Name | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 866.3740 |
| FDA Common Generic Name | STREP A TEST KIT |
| FDA Proprietary Device Name | DBEST STREP A 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 | ABON BIOPHARM (HANGZHOU) CO., LTD. HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA HANGZHOU, ZHEJIANG, 310018 CH 781-674-3900 / 858-200-8972 |
ACON STREP A RAPID TEST STRIP | STREP A TEST |
| 2 | ACCESS BIO INCORPORATE 2033 RT. 130 UNIT H MONMOUTH JUNCTION, NJ 08852 US 732-297-2222 / 732-297-2222 103 |
CARESTART STREP A | STREP A TEST |
| 3 | ACON BIOTECH (HANGZHOU) CO., LTD. 398 TIANMUSHAN RD. GUDANG INDUSTRIAL PARK HANGZHOU, P.R., 310023 CH 86-571-03963569 / 858-875-8000 1828 |
ACON STREP A RAPID TEST STRIP | STREP A TEST |
| 4 | ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 858-535-2030 / 858-875-8000 1828 |
ACON STREP A RAPID TEST STRIP | STREP A TEST |
| 5 | ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US 858-513-3888 / 858-513-3888 314 |
MULTIPLE | STREP A RAPID TEST |
| 6 | ANTIBODIES INC. 25242 CR 95 DAVIS, CA 95616 US 530-758-4400 / 530-758-4400 |
DETECT-A-STREP | DETECT-A-STREP |
| 7 | APPLIED BIOTECH 10237 FLANDERS CT. SAN DIEGO, CA 92121 US 781-674-3900 / 858-587-6771 |
MULTIPLE | VARIOUS STREP ANTIGENS |
| 8 | BECKMAN COULTER, INC. 606 ELMWOOD AVE. SHARON HILL, PA 19079 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS TYPES OF STREP A KITS |
| 9 | BECKMAN COULTER, INC. 1050 PAGE MILL RD., BLDG. 2-B PALO ALTO, CA 94303 US 714-871-4848 / 714-993-5321 8383 |
MULTIPLE | VARIOUS TYPES OF STREP A KITS |
| 10 | BECTON, DICKINSON & CO. 250 SCHILLING CIRCLE COCKEYSVILLE, MD 21030 US 201-847-6800 / 410-316-4000 4099 |
BBL DIRECTIGEN 1-2-3 GROUP A STREP | DIRECTIGEN 1-2-3 GROUP A STREP |
| 11 | BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US 781-674-3900 / 207-730-5740 |
EQUATE STREP A TEST | EQUATE STREP A TEST |
| 12 | BIOMERIEUX BRASIL ESTRADA MAPUA 491-JACAREPAGUA RIO DE JANEIRO -RJ, BR 33-478-872063 / 314-731-8594 |
SLIDEX STREP TO | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.#MICROBIOLOGY |
| 13 | BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594 |
SLIDEX STREPTO | SLIDEX STREPTO |
| 14 | BTNX, INC. 570 HOOD ROAD, UNIT 23 MARKHAM, L3R 4G7 CA 905-944-9565 / 303-234-9412 |
BIOTECHNOSTIX | STREPTOCOCCUS SPP. SEROLOGICAL REAGENTS |
| 15 | CARE DIAGNOSTICA GMBH 8 ROEMERSTRASSE MOELLERSDORF, 2513 AU 43-225-255150 / 541-850-9402 |
STREPTOCARE A, STREPTOCARE B | STREPTOCOCCUS GROUP A TEST, STREP B TEST |
| 16 | DIAGNOSTIC TEST GROUP, LLC 141 N.W. 20TH ST., SUITE F-2 BOCA RATON, FL 33431 US 561-347-5760 / 561-347-5760 |
CLARITY STREP A STRIPS AND TWIST CASSETTES | STREP A STRIPS AND TWIST CASSETTES |
| 17 | GENZYME DIAGNOSTICS 6659 TOP GUN ST. SAN DIEGO, CA 92121 US 617-252-7500 / 617-768-6275 |
OSOM (R) ULTRA STREP A TEST | GROUP A STREPTOCOCCUS ANTIGEN TEST |
| 18 | GERMAINE LABORATORIES, INC. 4139 GARDENDALE CENTER, SUITE 101 SAN ANTONIO, TX 78229 US 210-692-4192 / 210-692-4192 |
STREPAIM | VARIOUS TYPES, STREPTOCOCCUS TEST KIT |
| 19 | GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218 |
GLOBALEMED SMART CHECK STREP A TEST STRIP/DEVICE | STREP A TEST |
| 20 | IMMULAB, INC. 5420 S. JACKSON RD. EDINBURG, TX 78539 US 956-686-7988 / 956-207-7812 |
IMMUSTAT STREP A RAPID TEST STRIP | STREP A RAPID TEST STRIP |
| 21 | IMMUNO RESOURCES, INC. 415 SISTERDALE RD. BOERNE, TX 78006 US 830-537-6199 / 830-537-6199 |
MULTIPLE | VARIOUS TYPES OF STREPTOCOCCUS ANTIGENS |
| 22 | INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US 781-674-3900 / 858-200-8972 |
ACON STREP A RAPID TEST STRIP | STREP A TEST |
| 23 | INNOVATIVE MEDICAL TECHNOLOGIES 1532-A BORI ST, URB. BELISA RIO PIEDRAS, PR 00927 US 787-753-4009 / 787-753-4009 |
EXCEL STREP A RAPID TEST STRIP | STREP A TEST |
| 24 | INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-SAN DIE 4106 SORRENTO VALLEY BOULEVARD SAN DIEGO, CA 92121 US 781-674-3900 / 858-200-8972 |
ACON STREP A RAPID TEST STRIP | STREP A TEST |
| 25 | IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. LOUISVILLE, CO 80027 US 781-674-3900 / 303-530-6612 |
BIOSTAR ACCEAVA STREP A | IMMUNOASSAY FOR GROUP A STREPTOCOCCUS |
| 26 | JANT PHARMACAL CORP. 16255 VENTURA BLVD., SUITE 505 ENCINO, CA 91436 US 818-986-8530 / 818-986-8530 |
ACCUSTRIP STREP A TEST STRIP | TEST FOR GROUP A STREPTOCOCCUL ANTIGEN |
| 27 | MAST GROUP LTD. MAST HOUSE, DERBY RD. BOOTLE, MERSEYSIDE, L20 1EA UK / 441-519-33727 |
MASTASTREP | LATEX AGGLUTINATION KIT |
| 28 | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229 |
MERITEC-STREP GROUPING KIT | STREPTOCOCCUS GROUPING KIT |
| 29 | NEW HORIZONS DIAGNOSTICS CORP. 9110 RED BRANCH RD., STE. B COLUMBIA, MD 21045 US 410-992-9357 / 410-992-9357 222 |
SMART GROUP A STREP TEST | RAPID COLORMETRIC TEST KIT FOR GROUP A STREPTOCOCCUS SPP |
| 30 | PILOT INDUSTRIES 46 CANAL ST. ELLENVILLE, NY 12428 US 845-331-4300 287 / 845-647-7711 |
STREP A TEST | IMMUNOCHROMATOGRAPHIC TEST FOR DETECTION OF GROUP A STREPTOCOCCAL ANTIGEN |
| 31 | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852 US 732-274-1000 / 732-274-1000 |
STATUSFIRST STREP A | STREP A TEST |
| 32 | QUIDEL CORP. 10165 MCKELLAR CT. SAN DIEGO, CA 92121 US 858-552-1100 / 858-552-1100 7910 |
QUIDEL GROUP B STREP TEST | |
| 33 | REMEL EUROPE LTD REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT, DA2 6PT UK 412-490-8425 / 412-490-8425 |
MULTIPLE | VARIOUS STREP ANTIGENS |
| 34 | REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215 US 412-490-8425 / 412-490-8425 |
MULTIPLE | VARIOUS STREP ANTIGENS |
| 35 | STANBIO LABORATORY 1261 NORTH MAIN ST. BOERNE, TX 78006 US 830-249-0772 / 830-249-0772 |
QUSTRIP STREP A | STREP A TEST |
| 36 | TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800 |
UNI-GOLD STREP A TEST KIT | RAPID TEST FOR THE DETECTION OF STREP A ANTIGEN |
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