Home GUDID 25999860094153
Trigger Solutions Pack
Primary DI 25999860094153
Brand Trigger Solutions Pack
Company Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model 226491-TRP
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.
Published 2026-01-05
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name PPM General Purpose Reagent
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PPM General Purpose Reagent Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 25999860094153 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25999860094153 25999860094153
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 4 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 4 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 427395277 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05999860094180 Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer with ISE P700-3 2018-06-26 05999883586884 Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-1 2018-06-26 05999883586891 Pictus 400 Clinical chemistry analyzer Pictus 400 clinical chemistry analyzer W/out ISE P400-1 2018-06-26 15999860094170 5x TBS Wash Buffer TWB56 2025-12-11 05999860094173 5x TBS Wash Buffer TWB56 2025-12-11 05999860094227 Pictus 400 Clinical chemistry analyzer Pictus 400 clinical chemistry analyzer with barcod P400-3 2018-06-26 05999860094234 Pictus 400 Clinical chemistry analyzer Pictus 400 clinical chemistry analyzer with ISE an P400-4 2018-06-26 05999883586686 NA ELECTRODE, ISE MODULE NA+ Electrode 5201 2016-10-06 05999883586709 CL ELECTRODE, ISE MODULE Cl- Electrode 5203 2016-10-06 05999883586693 K ELECTRODE, ISE MODULE K+ Electrode 5202 2016-10-06 05999883586419 P780 Clinical Chemistry Analyzer with ISE module P780 Clinical Chemistry Analyzer with ISE module P780-1 2025-07-10 05999883586426 P780 Clinical Chemistry Analyzer P780 Clinical Chemistry Analyzer P780-2 2025-07-10 05999883586907 Atellica DT Cuvettes (280pcs) Atellica DT Cuvettes (280pcs) 11310512 2025-06-13 15999883586751 Atellica DT Solution 1 (S1) Atellica DT Solution 1 (S1) 11310507 2025-04-30 15999883586867 Atellica DT Solution 4 (S4) Atellica DT Solution 4 (S4) 11310510 2025-04-30 45999883586752 Atellica DT Solution 2 (S2) Atellica DT Solution 2 (S2) 11310508 2025-04-30 05999883586747 Atellica DT 250 Analyzer Atellica DT 250 11310504 2025-04-30 15999883586744 Atellica DT 250 Analyzer Atellica DT 250 11310504 2025-04-30 25999883586758 Atellica DT Solution 1 (S1) Atellica DT Solution 1 (S1) 11310507 2025-04-30 15999883586850 Atellica DT Solution 3 (S3) Atellica DT Solution 3 (S3) 11310505 2025-04-30
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00846405014194 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-09 00846405023417 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-09 00846405012305 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012312 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012329 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012411 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012428 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012435 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012459 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012466 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012473 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012497 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012503 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012510 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012527 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012534 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012541 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012558 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012565 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405012589 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405013432 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405014163 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405014170 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405014200 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405016730 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405016778 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405017133 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405017140 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405023219 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08 00846405023271 Diagnostic BioSystems Diagnostic Biosystems, Inc. PPM 2026-06-08