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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PREPSTAIN; PrepStain Density Reagent; PrepStain Settling Chambers; PrepStain Syringing Pipettes; PrepStain System; SurePath Liquid-Based Pap Test; SurePath PreCoat Slides
Classification Name: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Product Code: MKQ
Device Class: 3
Registered Establishment Name: TRIPATH IMAGING, INC
Registered Establishment Number: 3008007472
Owner/Operator: BECTON, DICKINSON & CO.
Owner/Operator Number: 9922032
Establishment Operations: Manufacturer; Specification Developer
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