TRUE METRIX

Basic Information

• Brand Name: TRUE METRIX
• Primary DI: 10840330706541
• Version / Model: TRUE METRIX Control Solution - Level 1 and Level 3 box
• Catalog Number: R5212-13
• Company Name: TRIVIDIA HEALTH, INC.
• Labeler DUNS: 151810868
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-25
• Public Version: 1
• Public Version Date: 2025-12-03
• Public Version Status: New
• Public Device Record Key: 854bde5f-c48b-4149-9fd4-2fa1dc7adc7e

Device Description

ProCure TRUE METRIX Control Solution box includes 3mL Control level 1, 3mL Control level 3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840330706545	GS1	CASE	48	In Commercial Distribution
Primary	10840330706541	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT FREEZE