QuantStudio(TM) Dx Software Version 1.0.4
Kit,qs DX SW V1.0.4
15manufacturers in China registered for this device type
1catalogue number
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 | Life Technologies Holdings Pte Ltd., Singapore |
|---|---|
| FDA product code | OOI |
| Device type | Real Time Nucleic Acid Amplification System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K123955 |
| Record published | 2021-04-19 |
| Record revised | 2024-06-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A48389 | 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.