Sensititre™ OptiRead™

GUDID 05032384474530

The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The reading is initiated via the Sensititre SWIN software and the data from the Sensititre™ OptiRead™ are then transferred back to the SWIN software where the results are generated. The device is for professional use only and is not intended for self-testing.

TREK DIAGNOSTIC SYSTEMS LIMITED

Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: 05032384474530
• NIH Device Record Key: 7d301da6-ec34-4404-87c5-4506b2bb9bc2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sensititre™ OptiRead™
• Version Model Number: V3030
• Company DUNS: 298203498
• Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com
• Phone: +441256694238
• Email: microbiology.techsupport.uk@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384474530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110583

FDA Product Code

• LRG: Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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: 2023-10-02
• Device Publish Date: 2023-09-22

Devices Manufactured by TREK DIAGNOSTIC SYSTEMS LIMITED

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• 05032384474530 - Sensititre™ OptiRead™: 2023-10-02The Sensititre™ OptiRead™ is used to read fluorescent values from Sensititre susceptibility and identification panels. The reading is initiated via the Sensititre SWIN software and the data from the Sensititre™ OptiRead™ are then transferred back to the SWIN software where the results are generated. The device is for professional use only and is not intended for self-testing.
• 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