Trigger Solutions Pack

Basic Information

• Brand Name: Trigger Solutions Pack
• Primary DI: 25999860094153
• Version / Model: 226491-TRP
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
• Labeler DUNS: 427395277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-05
• Public Version: 1
• Public Version Date: 2026-01-13
• Public Version Status: New
• Public Device Record Key: ef2825b8-cb58-46df-a102-39af12f42c68

Device Description

Trigger Solution 1 – Acid Reagent, Trigger Solution 2 – Base Reagent (“Trigger Solutions”) are required to generate the luminescent light signal in the fully automated chemiluminescence immunoassay (CLIA) analyzer KleeYa®. The Trigger Solutions are designed for the flash system, which implies the usage of an acridinium-labeled conjugate. The acridinium ester label undergoes an oxidative reaction when exposed to peroxide (Trigger Solution 1 – Acid Reagent) and an alkaline solution (Trigger Solution 2 – Base Reagent). The oxidized product is in an excited form. The return to its ground state is indicated by the emission of light, which is measured in a few seconds and is expressed in relative light units (RLU) by the KleeYa® instrument.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58793	Chemiluminescent immunoassay signal generation kit IVD	A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an immunoassay on a clinical specimen. The kit is typically used in conjunction with luminescent-labelled antibodies or antigens of known characterization and may also include reference material to optimise and verify performance of the luminometer instrument.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	25999860094153	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius