BIO-RAD URINE ALA BY COLUMN TEST MANUFACTURED BY BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI

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Request for Information Form	Contact Information
Company Name	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
Address	4000 ALFRED NOBEL DR.
City, State, Zip	HERCULES, CA 94547
Country	US
FDA Owner/Operator Phone	510-724-7000
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JKL
FDA Classification Name	ACID, DELTA-AMINOLEVULINIC, ION-EXCHANGE COLUMNS WITH COLORIMETRY
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1060
FDA Common Generic Name	ALA TEST METHOD
FDA Proprietary Device Name	BIO-RAD URINE ALA BY COLUMN TEST
FDA Owner / Operator Number	9929003
FDA Owner / Operator Name	BIO-RAD LABORATORIES, INC.
FDA Establishment Registration Number	2915274
FDA Registered Establishment Name	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-04-06
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 GMBH HEIDEMANNSTRASSE 164 MUNCHEN, D-80939 GM 510-724-7000 / 510-741-6263	DAVIS URINARY ALA TEST	ALA BY COLUMN TEST
2	PETER W. SEEH MEDICAL ZEUGHASSTR,103 TUTTLINGEN, 78532 GM	MULTIPLE	VARIOUS