Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST

GUDID M578V4000

The Thermo Scientific™ Sensititre™ ARIS HiQ™ System is a benchtop automated incubation and reading system for antimicrobial susceptibility testing and identification of bacterial pathogens; designed to accommodate up to 100 Sensititre™ microtitre plates within a single instrument.

TREK DIAGNOSTIC SYSTEMS LIMITED

Microorganism identification/antimicrobial-susceptibility analyser IVD

• Primary Device ID: M578V4000
• NIH Device Record Key: 2b9034ef-7f11-4a81-9834-27b751e85416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Scientific™ Sensititre™ ARIS HiQ™ System for AST
• Version Model Number: V4000
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M578V4000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191914

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-09-16
• Device Publish Date: 2020-01-17

Devices Manufactured by TREK DIAGNOSTIC SYSTEMS LIMITED

• 05032384571673 - Sensititre: 2024-08-02
• 05032384571680 - Sensititre: 2024-08-02
• 05032384571659 - Sensititre: 2024-08-02
• 05032384503513 - Sensititre: 2024-08-02
• 05032384474561 - Sensititre: 2024-08-02
• 05032384571505 - Sensititre: 2024-08-01
• 05032384571772 - Sensititre: 2024-08-01
• 05032384571802 - Sensititre: 2024-08-01