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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Isostat Microbial Tube Proc. System
Classification Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Product Code: JKA
Device Class: 2
Regulation Number: 862.1675
Medical Specialty: Clinical Chemistry
Registered Establishment Name: ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
Registered Establishment Number: 1221359
Owner/Operator: Alere, Inc.
Owner/Operator Number: 9006731
Establishment Operations: Specification Developer
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