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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Abbott Proteinase K 03L78-061; Abbott RealTime HBV; Abbott RealTime HBV Amplification Kit 02N40-090, 02N40-091; Abbott RealTime HBV Calibrator Kit 02N40-70; Abbott RealTime HBV CD-ROM 02N43; Abbott RealTime HBV Control Kit 02N40-80
Classification Name: HEPATITIS VIRAL B DNA DETECTION
Product Code: MKT
Device Class: 2
Regulation Number: 866.3174
Medical Specialty: Microbiology
Registered Establishment Name: ABBOTT MOLECULAR, INC.
Registered Establishment Number: 3005248192
Premarket Submission Number: P080026
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
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