Urine Reagent Strips, 1-parameter, glucose

Basic Information

• Brand Name: Urine Reagent Strips, 1-parameter, glucose
• Primary DI: 00664816000069
• Version / Model: URS-01PR-GL77
• Company Name: LW SCIENTIFIC, INC.
• Labeler DUNS: 785335381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: b59e7d8c-40df-4ff1-bf84-0c8445854825

Device Description

Urine reagent strips; 1-parameter; glucose; 100 strips per vial

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	862.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54518	Urine glucose IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for glucose within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to aid clinicians in the diagnosis and monitoring of diabetes. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00664816000069	GS1

Premarket Submissions

Submission Number	Supplement Number
K942648	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 15 – 30 Degrees Celsius