G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE MANUFACTURED BY TOSOH BIOSCIENCE, INC.

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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	HE - Hematology
FDA Product Code	JPD
FDA Classification Name	HEMOGLOBIN A2 QUANTITATION
FDA Device Classification Code	Standards
FDA Regulation Number	864.7400
FDA Common Generic Name	HEMOGLOBIN A2 ASSAY
FDA Proprietary Device Name	G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
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)	MM - Manufacturer MR - Remanufacturer 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

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	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	VARIANT II BETA-THALASSEMIA SHORT PROGRAM	VARIANT II B-THAL SHORT, OR VII BTS
2	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	BETA-THAL COLUMN KIT	HEMOGLOBIN A2-COLUMN CHROMATOGRAPHY
3	MULTISCIENCES (MSI), INC. 371 11TH AVE. LACHINE, QUEBEC, H8S 3G8 CA 207-384-4839 / 207-384-4839	MULTIPLE	VARIOUS
4	TOSOH BIOSCIENCE, INC. 3600 GANTZ ROAD GROVE CITY, OH 43123 US 813-542-75118 / 614-317-1909	G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMI MODE	HEMOGLOBIN A[BDI2] ASSAY