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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BD MAX™ System; BD MAX™ Vaginal Panel
Classification Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
Product Code: OUY
Device Class: 2
Regulation Number: 866.3860
Medical Specialty: Immunology
Registered Establishment Name: BECTON, DICKINSON & CO.
Registered Establishment Number: 1119779
Premarket Submission Number: DEN160001
Owner/Operator: Becton Dickinson and Company
Owner/Operator Number: 9922032
Establishment Operations: Manufacturer; Specification Developer; Complaint File Establishment
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