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

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AIA-PACK IRI, ST AIA-PACK IRI

Request for Information Form	Contact Information
Company Name	TOSOH BIOSCIENCE, INC.
Address	3600 GANTZ ROAD
City, State, Zip	GROVE CITY, OH 43123
Country	US
FDA Owner/Operator Phone	813-542-75118
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CFP
FDA Classification Name	RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1405
FDA Common Generic Name	IMMUNOREACTIVE INSULIN TEST SYSTEM
FDA Proprietary Device Name	AIA-PACK IRI, ST AIA-PACK IRI
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	3005529799
FDA Registered Establishment Name	TOSOH BIOSCIENCE, INC.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	10-24-05
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 LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	IMX INSULIN	INSULIN ASSAY
2	ADALTIS S.P.A. DIAGNOSTICS PLANT VIA LUIGI EINAUDI, 7 GUIDONIA MONTECELIO, ROMA, 00012 IT 514-335-9922 / 514-335-9922	MULTIPLE, INSULIN MAIA RIA KIT	INSULIN RADIOIMMUNOASSAY KIT
3	BECKMAN COULTER, INC. 445 MEDICAL CENTER BLVD. WEBSTER, TX 77598 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	VARIOUS
4	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS ULTRASENSITIVE INSULIN REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	INSULIN (ENZYME IMMUNOASSAY)
5	DAKO LTD. DENMARK HOUSE, ANGEL DROVE ELY, CAMBRIDGESHIRE, CB7 4ET UK 454-485-9500 / 805-566-5487	INSULIN ELISA KIT	IMMUNOREACTIVE INSULIN TEST SYSTEM
6	DENKA SEIKEN CO., LTD (KAGAMIDA FACILITY) 1359-1, KAGAMIDA, KIGOSHI GOSEN-SHI, NIIGATA, 959-1834 JA 81-3-36699421 / 81-250-420812	ARCHITECT(R) INSULIN REAGENTS	INSULIN IMMUNOASSAY
7	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	INSULIN BY RADIOIMMUNOASSAY	INSULIN RIA KIT
8	DRG INSTRUMENTS GMBH FRAUENBERGSTRASSE 18 MARBURG, D-35039 GM 908-233-2079 / 908-233-2079	IMMUNOREACTIVE INSULIN TEST SYSTEM	INSULIN
9	FUTURE DIAGNOSTICS B.V. NIEUWEWEG 172 6603 BT WYCHEN, 6603 BT NL 310-246-452900 / 312-464-52900	STAT-ISULIN KIT	STAT-ISULIN KIT
10	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	INSULIN MULTIPLE DIAGNOSIS PRODUCTS	INSULIN MULTIPLE DIAGNOSIS PRODUCTS
11	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN	RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
12	IVD TECHNOLOGIES 2002 S. GRAND AVE STE A SANTA ANA, CA 92705 US 714-549-5050 / 714-549-5050	FREE AND TOTAL INSULIN	FREE AND TOTAL INSULIN
13	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY INSULIN REAGENT AND CALIBRATOR	INSULIN REAGENT AND CALIBRATOR
14	KYOWA MEDEX CO., LTD. 600-1, MINAMI-ISHIKI, NAGAIZUMI-CHO SUNTO-GUN, SHIZUOKA-KEN, 411-0932 JA 81-3-62197600 / 81-55-988-6014	IRI	IMMUNOASSAY, IMMUNOREACTIVE INSULIN
15	LINCO RESEARCH,INC. 6 RESEARCH PARK DR. ST. CHARLES, MO 63304 US 636-441-8400 / 636-441-8400	HUMAN INSULIN SPECIFIC RIA KIT	INSULIN RADIOIMMUNOASSAY
16	MERCODIA AB SYLVENIUSGATAN 8A UPPSALA, SE-754 50 SW 46-18-57 00 70 / 336-725-8623	INSULIN(MULTIPLE DIAGNOSIS PRODUCTS)	INSULIN ASSAY
17	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	MULTIPLE	PROCEDURE FOR THE RIA OF HUMAN SERUM INSULIN
18	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US / 317-521-2834	INSULIN ENZYMUN	INSULIN ENZYMUN
19	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS INSULIN ASSAY	INSULIN IMMUNOASSAY
20	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN	RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
21	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 2000, IML 2500 INSULIN	RADIOIMUNOASSAY FOR THE MEASUREMENT OF INSULIN
22	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
23	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	COAT-A-COUNT, IMMULITE, IML 2000, IML 2500 INSULIN	RADIOIMUNOASSAY FOR THE MEASUREMENT OF INSULIN
24	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED GLYN RHONWY LLANBERIS, CAERNARFON, LL55 4EL UK 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 2000, IML 2500 INSULIN	RADIOIMMUNOASSAY FOR THE MEASUREMENT OF INSULIN
25	TOSOH AIA, INC. 2, IWASEKOSHI-MACHI TOYAMA, 931-8510 JA 813-542-75118 / 614-317-1909	AIA-PACK IRI, ST AIA-PACK IRI	IMMUNOREACTIVE INSULIN TEST SYSTEM
26	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	AIA-PACK IRI, ST AIA-PACK IRI	IMMUNOREACTIVE INSULIN TEST SYSTEM
27	WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109	IMMUNOREACTIVE INSULIN TEST SYSTEM	GLAZYME INSULIN-EIA TEST
28	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	AUTODELFIA INSULIN KIT	FLUOROIMMUNOASSAY FOR DETERMINATION OF HUMAN INSULIN