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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: T-SPOT.TB Test
Classification Name: MYCOBACTERIUM TUBERCULOSIS, CELL MEDIATED IMMUNE RESPONSE, ENZYME-LINKED IMMUNOSPOT TEST
Product Code: OJN
Device Class: 3
Registered Establishment Name: Oxford Immunotec Inc.
Registered Establishment Number: 3007066822
Owner/Operator: Oxford Immunotec Ltd
Owner/Operator Number: 10026700
Establishment Operations: Complaint File Establishment
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