Serodia TP-PA Kits
220 test kits
1manufacturer
2catalogue numbers in this listing
1510(k) clearance
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 |
|---|---|---|---|---|
| Zhuhai Livzon Diagnostics Inc. | Zhuhai | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Fujirebio Diagnostics, AB, Sweden |
|---|---|
| FDA product code | GMT |
| Device type | Antigens, Ha, Treponema Pallidum |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3830 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K971502 |
| Record published | 2023-12-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 56 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 234952 | 100 tests per kit | In distribution |
| 234976 | 220 tests per kit | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Serodia TP-PA | Fujirebio Diagnostics, AB | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K893124 | 1989-11-17 |
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.