TriVerity
The TriVerity cartridge is a single-use, disposable, multi-chambered fluidic cartridge that has been designed, manufactured, and validated for use only on the Myrna instrument. The…
The TriVerity cartridge is a single-use, disposable, multi-chambered fluidic cartridge that has been designed, manufactured, and validated for use only on the Myrna instrument. The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and noninfectious illness, as well as to determine the likelihood of 7-day need for mechanical ventilation, vasopressors, and/or renal replacement therapy in adult patients with suspected acute infection or suspected sepsis presenting to the emergency department.
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Sansure Biotech Inc. | Changsha | Hunan | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Real Time Nucleic Acid Amplification System
Record
| Listed by | Inflammatix, United States |
|---|---|
| FDA product code | OOI |
| Device type | Real Time Nucleic Acid Amplification System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Manufacturer |
| 510(k) | K241676 |
| Record published | 2026-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 76.142 to 101.32 KiloPascal; Storage environment humidity 20 to 80 % RH; Storage environment atmospheric pressure 76.142 to 101.32 KiloPascal |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRIVERITY-2000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GeneXpert Dx System | Cepheid | 37 |
| Alinity m | Abbott Molecular, Inc. | 20 |
| GeneXpert Infinity-80 System | Cepheid | 13 |
| Fluorescence Quantitative PCR Detection System | Anitoa Biotechnology(Hangzhou)Co., Ltd. | 12 |
| GeneXpert® | Cepheid | 10 |
| Certified Pre-Owned GeneXpert Dx System | Cepheid | 10 |
| Bioer GeneExplorer Thermal Cycler | Hangzhou Bioer Technology Co., Ltd. | 7 |
| m2000 | Abbott Molecular, Inc. | 5 |
| GeneXpert Infinity-48s System | Cepheid | 5 |
| Panther Fusion® | Hologic, Inc. | 4 |
| Bioer LineGene 9600 Plus Fluorescent Quantitative Detection System | Hangzhou Bioer Technology Co., Ltd. | 4 |
| Bioer QuantGene 9600 Fluorescent Quantitative Detection System | Hangzhou Bioer Technology Co., Ltd. | 3 |
Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System
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.