Sensititre

GUDID M578ESB1F2

TREK DIAGNOSTIC SYSTEMS LIMITED

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

• Primary Device ID: M578ESB1F2
• NIH Device Record Key: f8ddf247-6c00-41ff-a688-fde30cb1f185
• Commercial Distribution Discontinuation: 2024-07-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sensititre
• Version Model Number: ESB1F
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M578ESB1F0 [Unit of Use]
HIBCC	M578ESB1F2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031545

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-07-25
• Device Publish Date: 2016-09-24

On-Brand Devices [Sensititre]

• 05032384571819: OMADFAST
• M578FDANDSF2: FDANDSF
• M578ESB1F2: ESB1F