Macro & Micro-Test Fluorescence Immunoassay Analyzer
2 catalogue numbers from HWTS-IF1000, listed by Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China, under Fluorometer, For Clinical Use. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Jiangsu Macro & Micro-Test MED-Tech Co., Ltd., China |
|---|---|
| FDA product code | KHO |
| Device type | Fluorometer, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2560 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HWTS-IF1000 | In distribution | |
| HWTS-IF2000 | 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 |
| 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 |
| Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer Ryan | Carolina Liquid Chemistries | 1 |
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.