Trigger Solutions Pack
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…
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.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Takara Biotechnology (Dalian) Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent
Record
| Listed by | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag |
|---|---|
| FDA product code | PPM |
| Device type | General Purpose Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Premarket notification | Exempt |
| Record published | 2026-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 4 to 25 °C; Storage environment temperature 4 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 226491-TRP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 62 |
| Epredia | Richard-Allan Scientific LLC | 59 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 46 |
| Vysis | Abbott Molecular, Inc. | 34 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 33 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 25 |
| Immunalysis | Immunalysis Corporation | 22 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 22 |
| Bond | Leica Biosystems Newcastle Ltd | 16 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 16 |
| Synchron | Beckman Coulter, Inc. | 13 |
| Immy | Immuno-Mycologics, Inc. | 12 |
Showing 12 of 617. All products under General Purpose Reagent
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.