Hemoglobin Variants System
Hemoglobin Variants System Cation Exchange Mini-Columns
3manufacturers in China registered for this device type
2catalogue 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 |
| 510(k) | K171664 |
| Record published | 2020-07-01 |
| Record revised | 2023-01-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 250-0014 | In distribution | |
| 250-0014 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acquity | Waters Corporation | 14 |
| D-10 | Bio-Rad Laboratories Inc. | 3 |
| 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.