ABBOTT HTLV-I/HTLV-II EIA MANUFACTURED BY ABBOTT LABORATORIES

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Request for Information Form	Contact Information
Company Name	ABBOTT LABORATORIES
Address	100 AND 200 ABBOTT PARK RD.
City, State, Zip	ABBOTT PARK, IL 60064
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	MTP
FDA Classification Name	ANTIBODY TO HTLV-1, ELISA
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	IN-VITRO ENZYME IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HUMAN
FDA Proprietary Device Name	ABBOTT HTLV-I/HTLV-II EIA
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	1415939
FDA Registered Establishment Name	ABBOTT LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-12-97
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	BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US 33-478-872063 / 314-731-8594	VIRONOSTIKA HTLV-1/II MICROELISA SYSTEM	VIRONOSTIKA HTLV-1/II MICROELISA SYSTEM
2	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	HTLV 1/11 MULTIPLE DIAGNOSIS PRODUCTS	HTLV 1/11 MULTIPLE DIAGNOSIS PRODUCTS