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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: TB STAT PAK II
Classification Name: SYSTEM, NUCLEIC ACID AMPLIFICATION, MYCOBACTERIUM TUBERCULOSIS COMPLEX
Product Code: MWA
Device Class: 2
Regulation Number: 866.3372
Medical Specialty: Microbiology
Registered Establishment Name: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Registered Establishment Number: 2431980
Owner/Operator: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Owner/Operator Number: 2431980
Establishment Operations: U.S. Manufacturer of Export Only Devices
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