Simplexa™ C. auris Direct

Simplexa™ C. auris Direct - MOL3950

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the yeast Candida auris in a clinical specimen, using a nucleic acid technique (NAT).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SBT

Device Name: Device To Detect Microbial Colonization Directly From Clinical Specimens.

Device Class: 2

Physical State: Single-use assay with reagents and disposables and associated instrument system

Definition: 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.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Qualitative nucleic acid test

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Clinical specimens

Regulation Number: 866.3967

Third Party Flag: N

Medical Specialty: MI

Device Id: 20816101027198

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A