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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Alere NMP22 BladderChek Test; Alere NMP22 Test Kit; Matritech NMP22 Bladdercheck Test; Matritech NMP22 ELISA Test Kit; NMP22 BladderChek Test; NMP22 Test Kit
Classification Name: SYSTEM,TEST,TUMOR MARKER,FOR DETECTION OF BLADDER CANCER
Product Code: NAH
Device Class: 3
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: Manufacturer
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