binx io 1.002.101

GUDID 25060441760054

binx io CT/NG cartridge

BINX HEALTH LIMITED

Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 25060441760054
• NIH Device Record Key: 225c0689-36a8-419b-8dfe-48009b36c878
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: binx io
• Version Model Number: V1 (CT/NG)
• Catalog Number: 1.002.101
• Company DUNS: 347089851
• Company Name: BINX HEALTH 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060441760050 [Primary]
GS1	25060441760054 [Package]; Contains: 05060441760050; Package: Shipper [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200533

FDA Product Code

• QEP: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

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