Trigger Solutions Pack

GUDID 25999860094153

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.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Chemiluminescent immunoassay signal generation kit IVD

• Primary Device ID: 25999860094153
• NIH Device Record Key: ef2825b8-cb58-46df-a102-39af12f42c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trigger Solutions Pack
• Version Model Number: 226491-TRP
• Company DUNS: 427395277
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com
• Phone: +3612794400
• Email: sales@diatron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	25999860094153 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-13
• Device Publish Date: 2026-01-05

Devices Manufactured by Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

• 25999860094153 - Trigger Solutions Pack: 2026-01-13 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.
• 25999860094153 - Trigger Solutions Pack: 2026-01-13 Trigger Solution 1 – Acid Reagent, Trigger Solution 2 – Base Reagent (“Trigger Solutions”) are required to generate the
• 05999860094173 - 5x TBS Wash Buffer: 2025-12-19 The product is intended as a wash buffer for the chemiluminescence reaction in the fully automated chemiluminescence immunoassa
• 05999883586419 - P780 Clinical Chemistry Analyzer with ISE module: 2025-07-18 The Pictus 780 is an in vitro diagnostic analyzer made for the continuous and automatic execution of clinical chemistry tests, a
• 05999883586426 - P780 Clinical Chemistry Analyzer: 2025-07-18 The Pictus 780 is an in vitro diagnostic analyzer made for the continuous and automatic execution of clinical chemistry tests, a
• 05999883586907 - Atellica DT Cuvettes (280pcs): 2025-06-23 The cuvette strips are manufactured especially for Atellica® DT 250 Analyzer and are intended to use for performing tests only
• 15999883586744 - Atellica DT 250 Analyzer: 2025-05-08 The Atellica® DT 250 analyzer is a fully automated wet-chemistry analyzer for in vitro diagnostic use. The analyzer is used to
• 25999883586758 - Atellica DT Solution 1 (S1): 2025-05-08 Atellica DT Solution 1 (S1) contains stabilized and micro- filtered hypochlorite and detergents, for regular cleaning and rinsin
• 15999883586850 - Atellica DT Solution 3 (S3): 2025-05-08 Atellica DT Solution 3 (S3) contains concentrated detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s p