Myrna
The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to be used…
The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to be used by healthcare professionals, and exclusively with Inflammatix test cartridges. The Myrna instrument is a platform instrument that provides pneumatic, thermal, motor, and optical control to complete the steps in an assay and runs a classifier to process the data acquired and produce the test results. An included touch screen display provides the primary method of input and, in concert with a graphical user interface, guides the user through the steps necessary to initiate a run. An outward facing barcode scanner acts as the primary method for entering information into the instrument software during a normal test workflow.
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 |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 30 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 76.1 to 101.3 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MYRNA-1000 | 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.