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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BTA
Classification Name: SYSTEM,TEST,TUMOR MARKER,FOR DETECTION OF BLADDER CANCER
Product Code: NAH
Device Class: 3
Registered Establishment Name: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Registered Establishment Number: 3022762
Owner/Operator: POLYMEDCO, INC.
Owner/Operator Number: 9001475
Establishment Operations: U.S. Manufacturer of Export Only Devices
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