STP8F

GUDID 05032384569588

TREK DIAGNOSTIC SYSTEMS LIMITED

Multiple antibacterial susceptibility testing kit IVD

• Primary Device ID: 05032384569588
• NIH Device Record Key: d4e56ca6-9b55-4350-b593-814afa4b096e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STP8F
• Version Model Number: STP8F
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384569588 [Primary]
GS1	05032384584055 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202612

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: 2026-03-27
• Device Publish Date: 2026-03-19

Devices Manufactured by TREK DIAGNOSTIC SYSTEMS LIMITED

• 05032384569588 - STP8F: 2026-03-27
• 05032384569588 - STP8F: 2026-03-27
• 05032384571499 - Sensititre: 2025-04-21
• 05032384571482 - Sensititre: 2025-04-21
• 05032384571574 - Sensititre: 2025-04-21
• 05032384571758 - Sensititre: 2025-04-21
• 05032384580132 - Sensititre: 2025-04-21
• 05032384580613 - Sensititre: 2025-04-21
• M578GN2F2 - Sensititre: 2025-03-31