Variant II Turbo
VARIANT II TURBO Hemoglobin Testing System WITHOUT Computer
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | LDM |
| Device type | Instrumentation, High Pressure Liquid Chromatography |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 270-2601 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acquity | Waters Corporation | 14 |
| D-10 | Bio-Rad Laboratories Inc. | 3 |
| Hemoglobin Variants System | Bio-Rad Laboratories Inc. | 2 |
| D-100 | Bio-Rad Laboratories Inc. | 1 |
| Variant II | Bio-Rad Laboratories Inc. | 1 |
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.