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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Post Hybridization Wash Buffer Kit; ProbeCheck ALK Negative Control Slides; ProbeCheck ALK Negative Control Slides 06N38-005; ProbeCheck ALK Positive Control Slides; ProbeCheck ALK Positive Control Slides 06N38-010; Vysis ALK Break Apart FISH Probe Kit 06N38-020; Vysis ALK Break Apart FISH Probve Kit; Vysis Paraffin Pretreatment IV &; Vysis Paraffin Pretreatment IV and Post Hybridization Wash Buffer Kit 01N31-005
Classification Name: FLUORESCENCE IN SITU HYBRIDIZATION, ANAPLASTIC LYMPHOMA KINASE, GENE REARRANGEMENT
Product Code: OWE
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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