Xpert Flu
Xpert Flu kit; 10 test kit
1manufacturer
1catalogue number
2510(k) clearances naming this product code
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 | OQW |
| Device type | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3332 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2018-01-29 |
| Record revised | 2022-05-12 (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 |
| Storage | Storage environment temperature 2 to 28 °C |
| Distribution end date | 2022-05-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GXFLU-10A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Simplexa™ Influenza A H1N1 (2009) | DiaSorin Molecular LLC | 1 |
| Jbaids | BioFire Defense, LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120911 | 2012-05-18 |
| K103766 | 2011-04-21 |
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.