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510(k) DEN230092

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) by Diasorin Molecular, LLC — Product Code SBT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
July 15, 2024
Date Received
December 28, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device To Detect Microbial Colonization Directly From Clinical Specimens.
Device Class
Class II
Regulation Number
866.3967
Review Panel
MI
Submission Type

A device to detect microbial colonization directly from clinical specimens is a qualitative in vitro diagnostic device intended for the detection and identification of microbial-associated targets from patients who are suspected of being colonized with a microbial pathogen and may present a risk of transmission to other patients and health care workers. This device is intended to aid in the detection of microbial colonizers for the prevention and control of infection in healthcare settings when used in conjunction with clinical and laboratory findings.

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