The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus…
The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for xTAG® RVP Fast (Respiratory Viral Panel Fast) | Listed by | Luminex Molecular Diagnostics, Inc., Canada |
| FDA product code | OEM |
| Device type | Human Metapneumovirus (Hmpv) Rna Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Manufacturer |
| Record published | 2016-09-09 |
| Record revised | 2023-12-18 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -25 to -15 °C |
| Distribution end date | 2020-01-02 |
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.