Xpert Flu+RSV Xpress
The Xpert Flu+RSV Xpress assay detects and distinguishes influenza A, influenza B and respiratory syncytial virus RNA in nasopharyngeal swab samples. It is intended for samples from…
The Xpert Flu+RSV Xpress assay detects and distinguishes influenza A, influenza B and respiratory syncytial virus RNA in nasopharyngeal swab samples. It is intended for samples from patients with signs and symptoms of respiratory infection and runs on the GeneXpert Xpress system.
A single-use cartridge contains the reagents and fluid chambers for sample preparation and real-time reverse-transcription PCR. The analyser moves fluids through the cartridge, amplifies the target sequences and detects them, integrating these steps within the automated test.
Listed Item
Xpert Flu+RSV Xpress kit; 10 test kit
Internal Controls
A sample processing control checks processing and potential PCR inhibition. A probe check control monitors reagent rehydration, tube filling, probe integrity and dye stability. These controls support assessment of each cartridge’s test process.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Cepheid, United States |
|---|---|
| FDA product code | OCC |
| Device type | Respiratory Virus Panel Nucleic Acid Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K151226 |
| Record published | 2018-01-29 |
| Record revised | 2023-12-18 (version 7) |
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 |
| Storage | Storage environment temperature 2 to 28 °C |
| Distribution end date | 2022-05-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GXFLU+RSV-XP-10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Panther Fusion® | Hologic, Inc. | 4 |
| Prodesse | Hologic, Inc. | 4 |
| Solana | Diagnostic Hybrids, Inc. | 2 |
| Alere™ i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Silaris RSV Supplemental Pack | Mesa Biotech, Inc. | 1 |
| Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 1 |
| ID NOW Influenza A & B 2 Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Xpert Xpress Flu/RSV | Cepheid | 1 |
| ID NOW Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Simplexa™ Flu A/B & RSV Direct | DiaSorin Molecular LLC | 1 |
| Alere™ i Influenza A & B | Alere Scarborough, Inc. | 1 |
| Respiratory Virus Plus (RV+) Amplification Tray | Nanosphere, Inc. | 1 |
Showing 12 of 39. All products under Respiratory Virus Panel Nucleic Acid Assay System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181289 | 2018-08-15 |
| K180218 | 2018-07-24 |
| K171552 | 2017-12-19 |
| K162456 | 2017-02-13 |
| K162331 | 2017-02-09 |
| K151226 | 2015-12-03 |
| K142045 | 2014-11-22 |
| K123191 | 2012-12-21 |
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.