3 catalogue numbers from HQ 02,2 bottles /box (Level 1:1mL /bottl, listed by Urit Medical Electronic Co., Ltd., China, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Hemoglobin Control Solution | Listed by | Urit Medical Electronic Co., Ltd., China |
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 30 °C |
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.