RANDOX BILIRUBIN MANUFACTURED BY RANDOX LABORATORIES LIMITED

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Request for Information Form	Contact Information
Company Name	RANDOX LABORATORIES LIMITED
Address	36 LARGY ROAD
City, State, Zip	CRUMLIN, CO.ANTRIM,
Country	UK
FDA Owner/Operator Phone	44-28-90 422413
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GIG
FDA Classification Name	HEMOGLOBINOMETER
FDA Device Classification Code	Standards
FDA Regulation Number	864.7500
FDA Common Generic Name	BILIRUBIN
FDA Proprietary Device Name	RANDOX BILIRUBIN
FDA Owner / Operator Number	8020890
FDA Owner / Operator Name	RANDOX LABORATORIES, LTD.
FDA Establishment Registration Number	132281
FDA Registered Establishment Name	RANDOX LABORATORIES LIMITED
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-18-07
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	AMRESCO, INC. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 SOLON, OH 44139 US 440-349-1199 / 440-914-3409	AMRESCO CALCIUM REAGENT	CALCIUN REAGENT
2	HEMOCUE AB KUVETTGATAN 1 ANGELHOLM, SE-262 71 SW 464-314-5 82 00 / 800-881-1611 110	HEMOCUE HEMOGLOBIN PHOTOMETER	HEMOGLOBINOMETER
3	PORTABLE MEDICAL LABORATORIES, INC. 544 SOUTH NARDO AVE. SOLANA BEACH, CA 92075 US 858-755-7385 / 858-755-7385	ANEMIA BOTTLE	HEMOGLOBIN SCREENING DEVICE
4	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX BILIRUBIN	BILIRUBIN