AIA-PACK IGE II, ST AIA-PACK IGEII MANUFACTURED BY TOSOH BIOSCIENCE, INC.

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AIA-PACK IGE II, ST AIA-PACK IGEII

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	IM - Immunology
FDA Product Code	DGC
FDA Classification Name	IGE, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5510
FDA Common Generic Name	IMMUNOGLOBULINS A,G,M,D AND E IMMUNOLOGICAL TEST SYSTEM
FDA Proprietary Device Name	AIA-PACK IGE II, ST AIA-PACK IGEII
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	AMERITEK USA, INC. 125 130 ST. SE, #200 EVERETT, WA 98208 US 425-379-2580 / 425-379-2580	DBEST IGE TEST KIT	IGE TEST KIT
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS TOTAL IGE REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	IGE EIA
3	BIOKIT S.A. CAN MALE, S/N LLISSA D'AMUNT, BARCELONA, 08186 SP / 349-386-09000	MULTIPLE (QUANTIA IGE)	IGE LATEX AGGLUTINATION TEST
4	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	NA LATEX IGE KIT	NA LATEX IGE KIT
5	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	ANTI-HUMAN IGE SERUM (EPSILON CHAIN SPECIFIC)	ANTI-HUMLAN IGE SERUM,STANDARD GRADE AND IGG FRACTION
6	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	BIOCHECK IGE ELISA, MODEL B MULTIPLE DIAGNOSIS PRODUCTS	BIOCHECK IGE ELISA, MODEL B MULTIPLE DIAGNOSIS PRODUCTS
7	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	IGE, ANTIGEN, ANTISERUM, CONTROL	IGE, ANTIGEN, ANTISERUM, CONTROL
8	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351	QUANTA LITE	MITOCHONDRIA M2 ELISA KIT
9	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	K-ASSAY TOTAL IGE REAGENT AND CALIBRATOR	IGE ASSAY AND CALIBRATOR
10	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	ANTI HUMAN IGE ANTISERUM
11	PHADIA AB RAPSGATAN 7 UPPSALA, SE-754 50 SW 46-18-165000 / 46-18-163775	MULTIPLE	VARIOUS
12	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX IGE	IGE
13	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX IGE	IGE
14	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM, BT29 4QY UK 44-28-90 422413 / 442-894-422413	RANOX IGE	IGE
15	RANDOX LABORATORIES, LTD. 34 DIAMOND RD. CRUMLIN, CO. ANTRIM, BT29 4QY UK 44-28-90 422413 / 44-28-90422413	RANDOX IGE	IGE
16	SENITH BIOMED TEORANTA TULLY INDUSTRIAL PARK, BALLYNAHOWN CO. GALWAY, EI 353-91-593900 / 353-91-593900	ALLERGEN SCREEN POSITIVE CONTROL	HUMAN CONTROL SERUM FOR USE IN ALLERGEN AND FOOD ALLERGEN SCREENS
17	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	ALASTAT ALLERGEN-SPECIFIC IGE CONTROLS	IGE CONTROLS
18	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS:180 IMMUNOGLOBULIN E (IGE) ASSAY	IGE ANTIGEN
19	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT	SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
20	UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910	UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE	IGE, ANTIGEN, ANTISERUM, CONTROL