Healgen
The Healgen Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. It is designed to perform in vitro diagnostic tests on clinical…
The Healgen Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. It is designed to perform in vitro diagnostic tests on clinical specimens including drug urine test.
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 | Healgen Life Science LLC, United States |
|---|---|
| FDA product code | KHO |
| Device type | Fluorometer, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K251972 |
| Record published | 2026-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 30 °C |
| Packaging | Inner pack |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OG-H180 | 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.