GeneXpert®
Xpert® Xpress GBS
2manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Cepheid, United States |
|---|---|
| FDA product code | NJR |
| Device type | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3740 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2024-02-16 |
| Record revised | 2025-07-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XPRSGBS-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SmartCycler Dx System | Cepheid | 16 |
| Freeze-dried Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 3 |
| Panther Fusion® | Hologic, Inc. | 3 |
| Xpert GBS LB | Cepheid | 2 |
| Xpert® | Cepheid | 2 |
| Alethia™ Group B Streptococcus | Meridian Bioscience, Inc. | 1 |
| AmpliVue | Quidel Corp. | 1 |
| Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 1 |
| Revogene GBS LB | Meridian Bioscience, Inc. | 1 |
| NeuMoDxTM GBS Test Strip | Neumodx Molecular, Inc. | 1 |
| Solana | Diagnostic Hybrids, Inc. | 1 |
| Aries® GBS Assay | Luminex Corporation | 1 |
Showing 12 of 19. All products under Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222638 | 2023-09-27 |
| K203429 | 2022-05-09 |
| K121539 | 2012-11-02 |
| K062948 | 2006-12-08 |
| K060540 | 2006-07-25 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-04-01 | Not classified | Software design | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession. | 16 US, 3 ROW | 2011-06-20 |
| 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.