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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 Genotype II Amplification Including Uracil-N-Glycosylase (UNG) 08L21-066; Abbott RealTime HCV Genotype II Control Kit 08L21-080; Abbott RealTime HCV Genotype m2000 combined App Spec 08L21; Abbott RealTime HCV Gentoype II Amplification Reagent Kit 08L21-090
Classification Name: ASSAY, GENOTYPING, HEPATITIS C VIRUS
Product Code: OBF
Device Class: N
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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