AIA-PACK-IRI MANUFACTURED BY TOSOH CORP.

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Request for Information Form	Contact Information
Company Name	TOSOH CORP.
Address	SHIBA-KOEN FIRST BLDG. 3-8-2 SHIBA MINATO-KU
City, State, Zip	TOKYO,
Country	JA
FDA Owner/Operator Phone	813-542-75118
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	CFD
FDA Classification Name	SULFOPHOSPHOVANILLIN, COLORIMETRY, TOTAL LIPIDS
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1470
FDA Common Generic Name	ENZYME IMMUNOASSAY FOR INSULIN (IRI)
FDA Proprietary Device Name	AIA-PACK-IRI
FDA Owner / Operator Number	8031673
FDA Owner / Operator Name	TOSOH CORP.
FDA Establishment Registration Number	8031673
FDA Registered Establishment Name	TOSOH CORP.
FDA Operation Code(s)
FDA Listing Date
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	BIO PHASE DIAGNOSTICS LABORATORY 6625 KITIMAT RD., UNIT #51 MISSISSAUGA, ONTARIO, L5N 6J1 CA 905-567-9165 / 905-567-9165	TOTAL LIPIDS	SULFOPHOSPHOVANILLIN, COLORIMETRY, TOTAL LIPIDS
2	DR. BRUNO LANGE GMBH KOENIGSWEG 10 BERLIN, 14163 GM	LCK 161 TOTAL LIPIDS	REAGENT TOTAL LIPIDS
3	EAGLE DIAGNOSTICS, INC. 545 JEALOUSE WAY CEDAR HILL, TX 75104 US 972-293-1605 / 972-293-1605	NO PROPRIETARY NAME LISTED	SULFOPHOSPHOVANILLLIN, COLORIMETRY, TOTAL
4	STERLING DIAGNOSTICS, INC. 36645 METRO COURT STERLING HEIGHTS, MI 48312 US 810-979-9171 / 810-979-2141		TOTAL LIPIDS REAGENT SET