HealthyMe UTI Urinary Tract Infection Test Strips

Basic Information

• Brand Name: HealthyMe UTI Urinary Tract Infection Test Strips
• Primary DI: 00682607651009
• Version / Model: 765100
• Company Name: ACON LABORATORIES, INC.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 7a576b5b-d180-4e00-ac9b-8ad5aace663c

Device Description

Urinary Tract Infection home test

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
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)	Clinical Chemistry	862.1510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54520	Urine leukocyte 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 leukocytes 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. It is not intended to be used for self-testing.	No	Active
54521	Urine nitrite 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 nitrites 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. 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
Package	20682607651003	GS1	Carton	24	In Commercial Distribution
Primary	00682607651009	GS1
Unit of Use	00682607002085	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit