ST AIA-PACK TESTOSTERONE MANUFACTURED BY TOSOH AIA, INC.

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ST AIA-PACK TESTOSTERONE

Request for Information Form	Contact Information
Company Name	TOSOH AIA, INC.
Address	2, IWASEKOSHI-MACHI
City, State, Zip	TOYAMA,
Country	JA
FDA Owner/Operator Phone	813-542-75118
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CDZ
FDA Classification Name	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1680
FDA Common Generic Name	TESTOSTERONE TEST SYSTEM
FDA Proprietary Device Name	ST AIA-PACK TESTOSTERONE
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	9612316
FDA Registered Establishment Name	TOSOH AIA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-09-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of TOSOH AIA, 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 LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	ARCHITECT TESTOSTERONE	TESTOSTERONE
2	ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922	TESTOSTERONE RIA KIT (MULTIPLE BRANDS)	TESTOSTERONE RADIOIMMUNOASSAY
3	AXIS-SHIELD DIAGNOSTICS, LTD. THE TECHNOLOGY PARK DUNDEE, SCOTLAND, DD2 1XA UK 44-13-82 422000 / 441-382-422000	ABBOTT AXSYM TESTOSTERONE (MEIA)	AXSYM TESTOSTERONE (MEIA)
4	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
5	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACESS TESTOSTERONE ASSAY	TESTOSTERONE ASSAY
6	BIOCHECK, INC. 323 VINTAGE PARK DR. FOSTER CITY, CA 94404 US / 650-573-1968	BIOCHECK TESTOSTERONE EIA TEST KIT	TESTOSTERONE EIA TEST KIT
7	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	ARCHITECT SHBG	CHEMILUMINESCENT SHBG TEST
8	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS TESTOSTERONE (TEA) ASSAY	ENZYME-LINKED FLUORESCENT IMMUNOASSAY (ELFA) TESTOSTERONE
9	CTK BIOTECH, INC. 6748 NANCY RIDGE DR. SAN DIEGO, CA 92121 US 858-457-8698 / 858-457-8698	TESTOSTERONE DETECT ELISA KIT	TESTOSTERONE ELISA KIT
10	DIAGNOSTICS BIOCHEM CANADA, INC. 1020 HARGRIEVE RD. LONDON, ONTARIO, N6E 1P5 CA 519-681-8731 / 519-681-8731	TESTOSTERONE BY ENZYME IMMUNOASSAY (EIA)	TESTOSSTERONE ENZYME IMMUNOASSAY TEST SYSTEM
11	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	GAMMACOAT TESTOSTERONE RADIOIMMUNOASSAY KIT	TESTOSTERONE RADIOIMMUNOASSAY
12	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	TESTOSTERONE TEST SYSTEM	TESTOSTERONE
13	DRG INTL., INC. 1167 US HIGHWAY 22 MOUNTAINSIDE, NJ 07092 US 908-233-2079 / 908-233-2075	DRG AURICA ELISA TESTOSTERONE KIT	TESTOSTERONE ELISA KIT EIA1559
14	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	GLOBALEMED TESTOSTERONE EIA	TESTOSTERONE EIA TEST
15	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE	RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE
16	IBL GMBH FLUGHAFENSTRASSE, 52A HAMBURG, D-22335 GM 49-40-53289122 / 715-294-1752	IBL TESTOSTERONE LIA TEST KIT	TESTOSTERONE LIA TEST KIT
17	IFCI/CLONESYSTEMS SPA VIA MAGNANELLI 2 CASALECCHIO DI RENO, 40033 IT	EIGEN TESTOSTERONE	TESTOSTERONE
18	INTELLECARE INC. 3355 GARDEN BROOK DR. FARMERS BRANCH, TX 75234 US 972-919-9000 / 972-919-9000	TESTOSTERONE DETECT ELISA KIT	TESTOSTERONE ELISA KIT
19	INTELLECT, INC. 1900 PRESTON ROAD 267.243 PLANO, TX 75093 US 972-919-9000 / 972-919-9000	TESTOSTERONE DETECT ELISA KIT	TESTOSTERONE ELISA KIT
20	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	SEX HORMONE BINDING PROTEIN COATED TUBE IRMA	SHBG, SEX STEROID BINDING PROTEIN, SBP
21	QUALIGEN, INC. 2042 CORTE DEL NOGAL CARLSBAD, CA 92011 US 760-918-9165 / 760-918-9165 226	FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY	CHEMILUMINESCENCE ASSAY FOR THE DETERMINATION OF TOTAL TESTOSTERONE
22	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS TESTOSTERONE ASSAY	TESTOSTERONE ASSAY
23	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE TOTAL TESTOSTERONE, IRMA COUNT SHBG	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF SEX HORMONE BIN
24	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS TESTOSTERONE ASSAY	TESTOSTERONE
25	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE TOTAL TESTOSTERONE, IRMA COUNT SHBG	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF SEX HORMONE BIN
26	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 2000, IML 2500 TOTAL TESTOSTERONE, SHBG	IMMUNOMETRIC ASSAY FOR MEASUREMENT OF SEX HORMONE BIN
27	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	ST AIA-PACK TESTOSTERONE	TESTOSTERONE TEST SYSTEM
28	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	ST AIA-PACK TESTOSETERONE	TESTOSTERONE TEST SYSTEM
29	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	DELFIA SHBG KIT	FLUOROIMMUNOASSAY FOR THE DETERMINATION OF SEX HORMONE BINDING GLOBULIN\