HIV 1/2 STAT-PACK MANUFACTURED BY CHEMBIO DIAGNOSTIC SYSTEMS, INC.

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Request for Information Form	Contact Information
Company Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Address	3661 HORSEBLOCK RD.
City, State, Zip	MEDFORD, NY 11763
Country	US
FDA Owner/Operator Phone	631-924-1135
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	MWB
FDA Classification Name	KIT,TEST,SALIVA,HIV-1&2
FDA Device Classification Code
FDA Regulation Number	NULL
FDA Common Generic Name	IMMUNOCHROMATOGRPHIC ASSAY FOR DETECTION OF ANTIBODIES
FDA Proprietary Device Name	HIV 1/2 STAT-PACK
FDA Owner / Operator Number	2431980
FDA Owner / Operator Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
FDA Establishment Registration Number	2431980
FDA Registered Establishment Name	CHEMBIO DIAGNOSTIC SYSTEMS, INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-06-99
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	AESCULAP AG & CO. KG. AM AESCULAP PLATZ TUTTLINGEN, DONAU, D-78532 GM 49-74-6195-1548 / 610-984-9074	VARIOUS	VARIOUS
2	ORASURE TECHNOLOGIES, INC. 1745 EATON AVE. BETHLEHEM, PA 18018 US 610-882-1820 / 610-882-1820 5043	ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST	RAPID HIV TEST