Prodesse
Catalogue number PRO HMPV+ KIT, 100 REACTIONS, listed by Hologic, Inc., United States, under Human Metapneumovirus (Hmpv) Rna Assay System. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Hologic, Inc., United States |
|---|---|
| FDA product code | OEM |
| Device type | Human Metapneumovirus (Hmpv) Rna Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132200 |
| Record published | 2016-04-15 |
| Record revised | 2023-12-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-06-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRO HMPV+ KIT, 100 REACTIONS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Panther Fusion® | Hologic, Inc. | 1 |
| FilmArray® Respiratory Panel (RP) | BioFire Diagnostics, LLC | 1 |
| xTAG® RVP Fast (Respiratory Viral Panel Fast) | Luminex Molecular Diagnostics, Inc. | 1 |
| Lyra | Diagnostic Hybrids, Inc. | 1 |
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.