Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516742290
• Version / Model: 826-10
• Catalog Number: 826-10
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• Labeler DUNS: 988298840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2019-05-10
• Public Version Status: Update
• Public Device Record Key: 9d265996-07db-4174-b149-c537faad79d9
• Distribution End Date: 2019-01-01

Device Description

Lactate Standard (40 mg/dl)

Device Characteristics

• Single Use: No
• 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: Yes
• 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
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	862.1450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53346	Lactate IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of lactate in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516742290	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius