BIO-RAD VARIANT NBS SICKLE CELL PROGRAM 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	HE - Hematology
FDA Product Code	GKA
FDA Classification Name	ABNORMAL HEMOGLOBIN QUANTITATION
FDA Device Classification Code	Standards
FDA Regulation Number	864.7415
FDA Common Generic Name	SICKLE CELL PROGRAM
FDA Proprietary Device Name	BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
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	01-16-06
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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	PARAGON ACID HEMOGLOBIN
2	INTERLAB S.R.L. VIA RINA MONTI N.26 ROME, 00155 IT 390-694-12585 / 570-620-0198	MULTIPLE, INTERLAB ACID HEMOGLOBIN	ACID HEMOGLOBIN TEST SYSTEMS