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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Abbott RealTime HCV; Abbott RealTime HCV Amplification Kit 01N30-090; Abbott RealTime HCV Amplification Kit including UNG 01N30-66; Abbott RealTime HCV Calibration Kit 01N30-070; Abbott RealTime HCV CD-ROM 04N45; Abbott RealTime HCV Control Kit 01N30-80; Abbott RealTime HCV UNG Extended Use 01N30-067
Classification Name: ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
Product Code: MZP
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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