Afias TSH-SP
AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the…
AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic use at clinical laboratorues and POC sites for the quantitative measurement of thyroid stimulating hormone(TSH) levels in serum, sodium-heparinized plasma, or EDTA Plasma samples.
Who Else Makes It
Concentrated in Beijing (1), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Guangzhou Labsim Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 3 |
Record
| Listed by | Boditech MED Inc., South Korea |
|---|---|
| FDA product code | KHO |
| Device type | Fluorometer, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2560 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K170232 |
| Record published | 2017-10-31 |
| Record revised | 2020-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AFIAS TSH-SP | 24 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sofia | Quidel Corp. | 4 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 3 |
| AutoDELFIA Plate processor | Wallac OY | 2 |
| Victor EnLite | Wallac OY | 2 |
| AutoDELFIA Automatic Immunoassay System | Wallac OY | 2 |
| Fluorometer, For Clinical Use | Guangzhou Labsim Biotech Co., Ltd. | 2 |
| Macro & Micro-Test Fluorescence Immunoassay Analyzer | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | 2 |
| AutoDELFIA Sample processor | Wallac OY | 2 |
| Asfa® Scanner | MBD Co., Ltd. | 2 |
| VICTOR2 D | Wallac OY | 2 |
| Seeker™ | Baebies Inc. | 2 |
| Frend System | Nanoentek Inc | 2 |
Showing 12 of 34. All products under Fluorometer, For Clinical Use
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.