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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Express; Quanti-Flexx Tuberculosos-Sure; Rapid 1-2-3 Hema
Classification Name: MYCOBACTERIUM TUBERCULOSIS, CELL MEDIATED IMMUNE RESPONSE, ENZYME-LINKED IMMUNOSPOT TEST
Product Code: OJN
Device Class: 3
Registered Establishment Name: HEMA DIAGNOSTIC SYSTEMS LLC
Registered Establishment Number: 3003567343
Owner/Operator: HEMA DIAGNOSTIC SYSTEMS LLC
Owner/Operator Number: 9054545
Establishment Operations: Repackager/Relabeler
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