TRI-COUNT - PLATELET RICH PLASMA MANUFACTURED BY BIO-RAD LABORATORIES, DIAGNOSTIC GROUP

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Request for Information Form	Contact Information
Company Name	BIO-RAD LABORATORIES, DIAGNOSTIC GROUP
Address	524 STONE RD. SUITE A
City, State, Zip	BENICIA, CA 94510
Country	US
FDA Owner/Operator Phone	510-724-7000
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GJP
FDA Classification Name	CONTROL, PLATELET
FDA Device Classification Code	Standards
FDA Regulation Number	864.8625
FDA Common Generic Name	PLATELET CONTROL
FDA Proprietary Device Name	TRI-COUNT - PLATELET RICH PLASMA
FDA Owner / Operator Number	9929003
FDA Owner / Operator Name	BIO-RAD LABORATORIES, INC.
FDA Establishment Registration Number	2919376
FDA Registered Establishment Name	BIO-RAD LABORATORIES, DIAGNOSTIC GROUP
FDA Operation Code(s)	MM - Manufacturer RR - Repackager/Relabeller
FDA Listing Date
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	DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949	FLO-CHECK	PLATELET CONTROL
2	R & D SYSTEMS, INC. 614 MCKINLEY PL., N.E. MINNEAPOLIS, MN 55413 US 612-379-2956 / 800-328-2400 4413	PLATET CONTROL	PLATELET CONTROL MATERIAL
3	STAGO R & D 125 AVE. LOUIS ROCHE GENNEVILLIERS, 92230 FR 33-146-88 20 20 / 33-146-854851	RECOMBINANT PF4	PURIFIED RECOMBINANT PLATELET FACTOR 4 (PF4)