AIA-PACK T4, ST AIA-PACK T4 MANUFACTURED BY TOSOH BIOSCIENCE, INC.

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AIA-PACK T4, ST AIA-PACK T4

Request for Information Form	Contact Information
Company Name	TOSOH BIOSCIENCE, INC.
Address	6000 SHORELINE COURT SUITE 101
City, State, Zip	SOUTH SAN FRANCISCO, CA 94080
Country	US
FDA Owner/Operator Phone	813-542-75118
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CDX
FDA Classification Name	RADIOIMMUNOASSAY, TOTAL THYROXINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1700
FDA Common Generic Name	TOTAL THYROXINE TEST SYSTEM
FDA Proprietary Device Name	AIA-PACK T4, ST AIA-PACK T4
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	2950409
FDA Registered Establishment Name	TOSOH BIOSCIENCE, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
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 BIOSCIENCE, 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	MULTIPLE:IMX, AXSYM, ARCHITECT T4	VARIOUS T4 OR THYROXINE ASSAYS
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE:IMX, AXSYM, ARCHITECT T4	VARIOUS T4 OR THYROXINE ASSAYS
3	ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922	T-4 MAIA RIA KIT (MULTIPLE BRANDS)	T-4 RADIOIMMUNOASSAY
4	ANTIBODIES INC. 25242 CR 95 DAVIS, CA 95616 US 530-758-4400 / 530-758-4400	125-I - T4-SECOND ANTIBODY BUFFER SYSTEM	T4 RIA KIT
5	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
6	BIOMERICA, INC. 1533 MONROVIA AVE. NEWPORT BEACH, CA 92663 US 949-645-2111 / 949-645-2111 330	T-4 (RIA) KIT RIA METHOD FOR DETERMINATION OF SERUM THRYOXIN	T-4 (RIA) KIT RIA METHOD FOR DETERMINATION OF SERUM THRYOXINE
7	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	THYROXINE (T4) BY RADIOIMMUNOASSAY	T4 RIA KIT
8	MONOBIND, INC. 100 N. POINTE DR. LAKE FOREST, CA 92630 US 949-951-2665 / 949-951-2665		T4 RADIOIMMUNOASSAY TEST SYSTEM
9	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I	T 4 SOLID PHASE RADIOIMMUNOASSAY KIT 125 I
10	NEOMETRICS, A DIVISION OF NATUS 104 BELLEROSE AVE. EAST NORTHPORT, NY 11731 US 516-754-8080 / 516-754-8080	ACCUSCREEN TY
11	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	CEDIA T4	TOTAL THYROXIDINE TEST
12	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ENZYMUN TEST T4	ENZYMUN TEST T4 (ENZYME IMMUNE ASSAY)
13	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS T4 ASSAY	T4 ASSAY
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	MULTIPLE	TOTAL THYROXINE
16	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT NEONATAL T4, TOTAL T4	RADIOIMMUNOASSAY FOR MEASUREMENT OF THYROXINE (T4)
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT NEONATAL T4, TOTAL T4	RADIOIMMUNOASSAY FOR MEASUREMENT OF THYROXINE (T4)
18	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK T4, ST AIA-PACK T4	TOTAL THYROXINE TEST SYSTEM
19	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	VARIOUS TYPES OF T4 KITS	VARIOUS TYPES OF T4 KITS
20	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	MULTIPLE	FLUOROIMMUNOASSAY FOR THE DETERMINATION OF THYROXINE