binx io 3.001.001

GUDID 05060441760005

binx io instrument

BINX HEALTH LIMITED

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

• Primary Device ID: 05060441760005
• NIH Device Record Key: 09a3696e-071e-40ef-9638-024cfaed41c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: binx io
• Version Model Number: V1
• Catalog Number: 3.001.001
• Company DUNS: 347089851
• Company Name: BINX HEALTH LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060441760005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200533

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex 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: 2025-09-11
• Device Publish Date: 2025-09-03

On-Brand Devices [binx io]

• 25060441760054: binx io CT/NG cartridge
• 15060441760040: Female collection kit
• 15060441760033: Male collection kit
• 05060441760005: binx io instrument