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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: (240),; 3D Combination; and BacT/ALERT 3D60 Instrument; BacT/ALERT Blood Culturing System
Classification Name: SYSTEM, BLOOD CULTURING
Product Code: MDB
Device Class: 1
Regulation Number: 866.2560
Medical Specialty: Microbiology
Registered Establishment Name: bioMerieux, Inc.
Registered Establishment Number: 3031977134
Premarket Submission Number: K903505
Owner/Operator: BIOMERIEUX SA
Owner/Operator Number: 8020790
Establishment Operations: Complaint File Establishment
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