BETA-THAL COLUMN KIT MANUFACTURED BY HELENA LABORATORIES

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Request for Information Form	Contact Information
Company Name	HELENA LABORATORIES
Address	1530 LINDBERGH DR.
City, State, Zip	BEAUMONT, TX 77704
Country	US
FDA Owner/Operator Phone	409-842-3714
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-COLUMN CHROMATOGRAPHY
FDA Proprietary Device Name	BETA-THAL COLUMN KIT
FDA Owner / Operator Number	1618982
FDA Owner / Operator Name	HELENA LABORATORIES
FDA Establishment Registration Number	1618982
FDA Registered Establishment Name	HELENA LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-07-06
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	MULTISCIENCES (MSI), INC. 371 11TH AVE. LACHINE, QUEBEC, H8S 3G8 CA 207-384-4839 / 207-384-4839	MULTIPLE	VARIOUS
3	TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US 813-542-75118 / 614-317-1909	G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE	HEMOGLOBIN A2 ASSAY
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