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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: UROVYSION BLADDER C ANCER KIT
Classification Name: TEST, FLUORESCENCE IN SITU HYBRIDIZATION (FISH), FOR BLADDER CANCER DETECTION AND MONITORING FOR RECURRENCE
Product Code: NSD
Device Class: 3
Registered Establishment Name: ABBOTT MOLECULAR, INC.
Registered Establishment Number: 3005248192
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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