Sensititre

GUDID 05032384571819

TREK DIAGNOSTIC SYSTEMS LIMITED

Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD Multiple antibacterial susceptibility testing kit IVD

• Primary Device ID: 05032384571819
• NIH Device Record Key: 38986b6e-5353-43f3-bd2d-72212f03d90b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensititre
• Version Model Number: OMADFAST
• Company DUNS: 298203498
• Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com
• Phone: 8006427029
• Email: info.Trek.US@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384522934 [Primary]
GS1	05032384571819 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183324

FDA Product Code

• JWY: Manual Antimicrobial Susceptibility Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

Devices Manufactured by TREK DIAGNOSTIC SYSTEMS LIMITED

• 05032384571819 - Sensititre: 2024-03-14
• 05032384571819 - Sensititre: 2024-03-14
• 05032384474509 - Sensititre™ Vizion™: 2023-10-02 Sensititre™ Vizion™ is an instrument that takes a digital image of a Sensititre susceptibility plate and sends it to the SWI
• 05032384474530 - Sensititre™ OptiRead™: 2023-10-02 The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The
• 05032384497409 - Sensititre AIM™: 2023-10-02 The product trade name is Sensititre AIM™. The product is a microprocessor-controlled automated inoculation delivery system. I
• M578V4000 - Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST: 2022-09-16 The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobia