binx io

Basic Information

• Brand Name: binx io
• Primary DI: 05060441760043
• Version / Model: V1 (CT/NG)
• Catalog Number: 5.012.001
• Company Name: BINX HEALTH LIMITED
• Labeler DUNS: 347089851
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-03
• Public Version: 1
• Public Version Date: 2025-09-11
• Public Version Status: New
• Public Device Record Key: d0c8f2f1-ab74-49d1-b040-1d768ac7f4d3

Device Description

Female collection kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIO	Device, Specimen Collection	Microbiology	866.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61144	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060441760040	GS1	Foil pouch	50	In Commercial Distribution
Primary	05060441760043	GS1

Premarket Submissions

Submission Number	Supplement Number
K200533	000