PGDx Elio™ Platform
Catalogue number B0110900, listed by Personal Genome Diagnostics Inc., United States, under Next Generation Sequencing Based Tumor Profiling Test. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Geneseeq Medical Device AND Diagnostic Inc. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Personal Genome Diagnostics Inc., United States |
|---|---|
| FDA product code | PZM |
| Device type | Next Generation Sequencing Based Tumor Profiling Test |
| Device class | Class 2 |
| Regulation | 21 CFR 866.6080 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K192063 |
| Record published | 2020-05-11 |
| Record revised | 2024-08-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B0110900 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PGDx elio™ server | Personal Genome Diagnostics Inc. | 4 |
| PGDx elio™ tissue complete | Personal Genome Diagnostics Inc. | 2 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) | Geneseeq Technology Inc. | 1 |
| Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq software | Geneseeq Technology Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192063 | 2020-04-24 |
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.