Sensititre

GUDID M578GN4F2

TREK DIAGNOSTIC SYSTEMS LIMITED

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

• Primary Device ID: M578GN4F2
• NIH Device Record Key: cba5c021-2565-4eb1-b597-2f5882c6a994
• Commercial Distribution Discontinuation: 2025-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Sensititre
• Version Model Number: GN4F
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M578GN4F0 [Unit of Use]
HIBCC	M578GN4F2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083606

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: 2025-03-31
• Device Publish Date: 2016-09-24

On-Brand Devices [Sensititre]

• 05032384571819: OMADFAST
• M578FDANDSF2: FDANDSF
• M578ESB1F2: ESB1F
• M578YO3IVD2: YO3IVD
• M578YO2IVD2: YO2IVD
• 05032384548606: CMT1DSTF
• 05032384575466: CMC1OUNF
• 05032384569151: CMC1AXPF
• 05032384569120: CMC6VGNF
• 05032384511419: CMC1YOGV
• 05032384505913: CMC1GNCC
• 05032384571321: YO4IVD
• 05032384529247: MDRGN2F
• 05032384501311: FDANDSF
• 05032384497546: CMC5MDOH
• 05032384474288: ESB1F
• 05032384571635: CMC1OUPF
• 05032384571628: MDRGN4F
• 05032384571697: CMC1MDNF
• 05032384571703: GNUR5F
• 05032384571727: MDRGN3F
• 05032384571710: STP7F
• 05032384575459: CMT1DGPF
• 05032384544554: CMC1GPVF
• 05032384571734: CMC5VGPF
• 05032384571796: CMC4VGPF
• 05032384571666: CMC5VGNF
• 05032384571802: CMC9ARUP
• 05032384571772: MEROVAB
• 05032384571505: CMC3VGPF
• 05032384474561: YO2IVD
• 05032384503513: YO3IVD
• 05032384571659: CMC1GPUF
• 05032384571680: CMC7AFLF
• 05032384571673: CMC6AFLF
• M578STP6F2: STP6F
• M578NF2: NF
• M578GPALL1F2: GPALL1F
• M578GNUR3F2: GNUR3F
• M578GN4F2: GN4F
• M578GN3F2: GN3F
• M578GN2F2: GN2F
• 05032384580613: ARUP1MDF
• 05032384580132: HPB2
• 05032384571758: GN7F
• 05032384571574: FDANDPF
• 05032384571482: GPALL3F
• 05032384571499: GPN3F