TEST1 THL
TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Alifax SRL, Italy |
|---|---|
| FDA product code | GKB |
| Device type | Device, Automated Sedimentation Rate |
| Device class | Class 1 |
| Regulation | 21 CFR 864.5800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-06 |
| Record revised | 2025-10-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 65 °C |
| Distribution end date | 2023-10-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TEST1 THL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Starrsed | Mechatronics USA | 16 |
| Vision ESR Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 12 |
| Excyte® | ELITechGroup B.V. | 4 |
| Latex Controls | Alifax SRL | 4 |
| Latex EQE (2 Test) | Alifax SRL | 3 |
| Latex Calibrators | Alifax SRL | 2 |
| Starrsed Control | RR Mechatronics Manufacturing B.V. | 2 |
| Excyte® ESR Vacuum Tube, Carton | ELITechGroup Inc | 2 |
| ESR-Auto Plus | Streck LLC | 2 |
| Roller 20 | Alifax SRL | 2 |
| Sediplus® S 2000 NX | Sarstedt Aktiengesellschaft & Co.KG | 2 |
| Excyte 20 | ELITechGroup Inc | 2 |
Showing 12 of 47. All products under Device, Automated Sedimentation Rate
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.