Fluorometer, for Clinical Use
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes
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 | Guangzhou Labsim Biotech 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 | 2020-05-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AFS2000A | In distribution | |
| AFS-1000 | 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 |
| 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 |
| 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.