Atida Urinary Tract Infection Test

Basic Information

• Brand Name: Atida Urinary Tract Infection Test
• Primary DI: 00810164510624
• Version / Model: U021ST-URS-US
• Company Name: ACESO LABORATORIES INC.
• Labeler DUNS: 003099455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-23
• Public Version: 1
• Public Version Date: 2026-03-31
• Public Version Status: New
• Public Device Record Key: fc63a022-2e6b-4e3c-afe1-9796d4151698

Device Description

EN, 1T, NON-CE, FDA

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
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1
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
Primary	00810164510624	GS1

Premarket Submissions

Submission Number	Supplement Number
K252607	000