GeneXpert Dx System
Cepheid GeneXpert Dx is an automated nucleic-acid testing platform that combines sample preparation, amplification and target detection in an integrated instrument workflow. Compatible…
Cepheid GeneXpert Dx is an automated nucleic-acid testing platform that combines sample preparation, amplification and target detection in an integrated instrument workflow. Compatible assay cartridges supply the specific reagents and target design for each test.
The listing identifies a GeneXpert Xpress System model GXIV-CLIA-L within the GeneXpert Dx family. The system processes assay-specific cartridges and software reports the result for the selected assay.
Listed Item
Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXIV-CLIA-L Additional catalog numbers: 900-0513-HE, 900-0513R
Cartridge-Based Workflow
GeneXpert automates sample preparation, nucleic-acid amplification and target detection within the instrument workflow. The assay cartridge supplies test-specific reagents and determines the target being measured.
The filed GXIV-CLIA-L configuration belongs to the GeneXpert Dx family. Result generation depends on the selected compatible cartridge, so the platform identity alone does not specify an assay target.
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 | Cepheid, United States |
|---|---|
| FDA product code | OOI |
| Device type | Real Time Nucleic Acid Amplification System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K060540 |
| Record published | 2016-09-12 |
| Record revised | 2025-07-14 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -30 to 45 °C |
| Distribution end date | 2022-05-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GXXVI-8 | In distribution | |
| GXIV-1 | In distribution | |
| GXXVI-8, GXXVI-12 | In distribution | |
| GXXVI-12 | In distribution | |
| GXIV-2 | In distribution | |
| GXXVI-16 | In distribution | |
| GXIV-1 | In distribution | |
| GXXVI-8 | In distribution | |
| GXIV-2 | In distribution | |
| GXII-2 | In distribution | |
| GXXVI-4, GXXVI-4-8 | In distribution | |
| GXIV-1 | In distribution | |
| GXXVI-16 | In distribution | |
| GXIV-3 | In distribution | |
| GX-I | In distribution | |
| GXI-1 | In distribution | |
| GXXVI-4 | In distribution | |
| GXXVI-12 | In distribution | |
| GXIV-3 | In distribution | |
| GXXVI-16 | In distribution | |
| GXIV-2 | In distribution | |
| GXXVI-4 | In distribution | |
| GXIV-4 | In distribution | |
| GXIV-4 | In distribution | |
| GXIV-3 | In distribution | |
| GXIV-4 | In distribution | |
| GX-I | In distribution | |
| GXIV-2 | Withdrawn | |
| GXXVI-16 | Withdrawn | |
| GXIV-3 | Withdrawn | |
| GXXVI-4 | Withdrawn | |
| GXII-1 | Withdrawn | |
| GXII-2 | Withdrawn | |
| GXIV-4 | Withdrawn | |
| GXXVI-12 | Withdrawn | |
| GXXVI-8 | Withdrawn | |
| GXIV-1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Q-Vera Prima 96 qPCR Instrument | Sansure Biotech Inc. | 3 |
Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cepheid | 510(k) number | 2007-09-05 | Not classified | Release of Material/Component prior to receiving test results | Labeling Error: Some cartridges may be mislabeled as “Xpert EV” instead of “Xpert GBS”. (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file) | 105 | 2008-04-04 |
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.