HemoTrol Duo
HemoTrol Duo is an assayed quality control material used by professionals to verify the performance of HemoCue Hb 301 and Hb 801 hemoglobin systems. It is supplied at low, normal and high…
HemoTrol Duo is an assayed quality control material used by professionals to verify the performance of HemoCue Hb 301 and Hb 801 hemoglobin systems. It is supplied at low, normal and high hemoglobin levels for routine quality control.
The liquid contains stroma free bovine hemolysate with hemoglobin in cyanmethemoglobin form, together with a bioburden controlling agent. It provides a reference material for checking the analyzer rather than a patient blood specimen.
Listed Item
HemoTrol® Duo is an assayed quality control material for professional use to verify the performance characteristics of the HemoCue® Hb 301 and HemoCue® Hb 801 System. HemoTrol® Duo is intended for the quantitative determination of hemoglobin.
Bottle Identification
Each reclosable bottle contains 1 mL. Cap colors identify the level: red for low, white for normal and blue for high. Two bottles of the same level are packaged together with instructions and a value sheet.
Who Else Makes It
Concentrated in Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Eurotrol B.V., Netherlands |
|---|---|
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K192842 |
| Record published | 2019-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Low | In distribution | |
| High | In distribution | |
| Normal | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eurotrol | Eurotrol B.V. | 11 |
| CueSee® Co-OX | Eurotrol B.V. | 11 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 10 |
| Liquichek | Bio-Rad Laboratories Inc. | 8 |
| InteliQ | Bio-Rad Laboratories Inc. | 4 |
| Hemoglobin Test Strip | Urit Medical Electronic Co., Ltd. | 3 |
| Lyphochek | Bio-Rad Laboratories Inc. | 3 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| HemoTrol WB | Eurotrol B.V. | 3 |
| Hemoglobin Control Solution | Urit Medical Electronic Co., Ltd. | 3 |
| Hemoglobin Meter | Urit Medical Electronic Co., Ltd. | 2 |
| Henry Schein | Henry Schein, Inc. | 1 |
Showing 12 of 25. All products under Control, Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192842 | 2019-11-15 |
| K182744 | 2019-02-01 |
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.