D-10
D-10 Hemoglobin Testing System
3manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | 2023-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature 10 to 95 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12010405 | 1 each | In distribution |
| 2200220 | 1 each | In distribution |
| 2200600 | 1 each | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acquity | Waters Corporation | 14 |
| Hemoglobin Variants System | Bio-Rad Laboratories Inc. | 2 |
| D-100 | Bio-Rad Laboratories Inc. | 1 |
| Variant II | Bio-Rad Laboratories Inc. | 1 |
| Variant II Turbo | 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.