THYROXINE, T4 DETECT ELISA KIT MANUFACTURED BY CTK BIOTECH, INC.

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THYROXINE, T4 DETECT ELISA KIT

Request for Information Form	Contact Information
Company Name	CTK BIOTECH, INC.
Address	6748 NANCY RIDGE DR.
City, State, Zip	SAN DIEGO, CA 92121
Country	US
FDA Owner/Operator Phone	858-457-8698
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	KLI
FDA Classification Name	ENZYME IMMUNOASSAY, NON-RADIOLABELED, TOTAL THYROXINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1700
FDA Common Generic Name	THYROXINE, T4 ELISA KIT
FDA Proprietary Device Name	THYROXINE, T4 DETECT ELISA KIT
FDA Owner / Operator Number	9051784
FDA Owner / Operator Name	CTK BIOTECH, INC.
FDA Establishment Registration Number	2032682
FDA Registered Establishment Name	CTK BIOTECH, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	12-24-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of CTK BIOTECH, 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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	IMX T4	FLUORESCENCE POLARIZATION IMMUNOASSAY (FPIA) FOR THE QUANTITAVIVE DETERMINATION
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	IMX T4	FLUORESCENCE POLARIZATION IMMUNOASSAY (FPIA) FOR THE QUANTITAVIVE DETERMINATION
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS TOTAL T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	T4 EIA
4	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	THYROXINE (T4)
5	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	THYROXINE (T4)
6	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	BIOCHECK T4 EIA TEST KIT	TOTAL THYROXINE EIA TEST KIT
7	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS THYROXINE (T4) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY FOR THYROXINE
8	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS THYROXINE (T4) ASSAY	ENZYME LINKED FLUORESCENT IMMUNOASSAY FOR THYROXINE
9	CHEMUX BIOSCIENCE, INC. 50 SOUTH LINDEN AVE. #7 SOUTH SAN FRANCISCO, CA 94080 US 650-872-1800 / 650-872-1800	CHEMUX TOTAL T4 EIA KITS	TOTAL THYROXINE(T4) ENZYME IMMUNOASSAY KITS
10	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS THYROXINE METHODS
11	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED T4 EIA	TOTAL THYROXINE EIA TEST
12	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US 800-436-2436 / 443-367-5501	MULTIPLE	VARIOUS THYROXINE METHODS
13	MICROGENICS CORP. 46360 FREMONT BLVD FREMONT, CA 94538 US 412-490-8425 / 412-490-8425	CEDIA T4 ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF TOTAL THYROXINE LEVELS I
14	MICROGENICS CORPORATION 44560-44660 OSGOOD RD FREMONT, CA 94539 US 412-490-8425 / 412-490-8425	CEDIA T4 ASSAY	HOMOGENEOUS ENZYME IMMUNOASSAY FOR THE DETERMINATION OF TOTAL THYROXINE LEVELS I
15	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665	TOTAL THYROXINE (T4) MICROPLATE	TOTAL THYROXINE (T4) MICROPLATE
16	MYERS-STEVENS GROUP 2931 VAIL AVE. COMMERCE, CA 90040 US 323-721-8552 / 903-566-6696	V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT	EIA TEST FOR THE QUANTITATION OF THYROXIN
17	NEO-GENESIS, A DIVISION OF NATUS 15410 SE 82ND DR. SUITE 270 CLACKAMAS, OR 97015 US 503-657-8000 / 503-657-8000	ACCUWELL T4 EIA	TOTAL THYROXINE TEST SYSTEM
18	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	KODAK AMERLITE TOTAL T-4 ASSAY (LAN.0002/2002) & T-3 ASSAY (LAN.2003/0003)	TOTAL THYROXINE TEST SYSTEM & TOTAL TRIIODOTHYRONINE TEST SYSTEM NRIA
19	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	NONE	NONE
20	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 TOTAL T4	RADIOIMMUNOASSAY FOR THE MEASUREMENT OF TOTAL T4
21	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 TOTAL T4	RADIOIMMUNOASSAY FOR THE MEASUREMENT OF TOTAL T4
22	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MAGIC LITE T4 COMBINATION BULK PHASE/LITE REAGENT 400 TESTS	T4 REAGENT
23	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 TOTAL T4	RADIOIMMUNOASSAY FOR THE MEASUREMENT OF TOTAL T4
24	TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. ANAHEIM, CA 92807 US 714-693-7788 / 714-693-7788	NONE	T4 (TOTAL THYROXINE) EIA MICROTITER ASSAY
25	TOSOH CORP. SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU TOKYO, 105-8623 JA 813-542-75118 / 614-317-1909	AIA-PACK-T4	ENZYME IMMUNOASSAY FOR TOTAL THYROXINE (T4)
26	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES OF T4 ENZYME IMMUNOASSAYS
27	UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910	UBI MAGIWEL THYROXINE(T4) QUANTITATIVE	TOTAL THYROXINE(T4)