PyloPlus+ Rapid Urease Test

Basic Information

• Brand Name: PyloPlus+ Rapid Urease Test
• Primary DI: 00860001810394
• Version / Model: PYLO-50
• Company Name: Arj Medical, Inc.
• Labeler DUNS: 006808397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2025-01-29
• Public Version: 1
• Public Version Date: 2025-02-06
• Public Version Status: New
• Public Device Record Key: 826a77a0-06d3-4235-ad6c-b03e5047e1ef

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYR	Helicobacter Pylori	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52787	Helicobacter pylori urease IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Helicobacter pylori bacteria urease enzyme in a clinical specimen, using a chromogenic test method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001810394	GS1
Unit of Use	10860001810391	GS1

Premarket Submissions

Submission Number	Supplement Number
K052708	000