Stix

Basic Information

• Brand Name: Stix
• Primary DI: 00860002060439
• Version / Model: 1
• Company Name: Get Stix Inc.
• Labeler DUNS: 117116737
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 3
• Public Version Date: 2021-05-18
• Public Version Status: Update
• Public Device Record Key: b8388dcc-cdde-4603-a4bb-47e3142ccc03

Device Description

Three UTI tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJX	TEST, URINE LEUKOCYTE	Hematology	864.7675	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63695	Urine test strip colour chart IVD	A device in the form of a printed chart designed for the qualitative and semi-quantitative assessment of urine analyte (e.g., ketones, glucose, nitrites, leukocytes) concentration/pH by visually comparing urine test strip colour with a standard scale of colour variations that correlate with urine analyte concentration/pH. It is typically used to screen paediatric urine by clinicians in a healthcare facility or by laypersons in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850024942073	GS1
Primary	00860002060439	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063295	000