ALiA FIA Analyser
ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed…
ALiA FIA Analyser (model: DX320) is a rapid and portable rapid diagnostic platform with integrated microfluidic biochips (Lab-On-Chips) technology. Only a single drop of sample is needed for this immunoassay based in vitro diagnostic platform to deliver an end-to-end solution from sample to result in less than 15 minutes. ALiA FIA Analyser is intended to be used alongside with IVD and other test kits developed by Sanwa BioTech. ALiA is to be used for the detection of fluorescent signals in immunoassays for the identification of biomarkers in near-patient testing or for laboratory use.
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 | Sanwa Biotech Limited |
|---|---|
| FDA product code | KHO |
| Device type | Fluorometer, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2560 |
| Record published | 2021-01-27 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity 20 to 80 % RH; Storage environment temperature 5 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DX320 | 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.