Research and Diagnostic Systems
R&D Glu/Hgb: 3 X 1.5mL Sample Pack (1 of each level)
2manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Research AND Diagnostic Systems, Inc. |
|---|---|
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| 510(k) | K070334 |
| Record published | 2016-07-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 2 to 8 °C; Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 4.5 to 10 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SQC001 | Total Volume 5 ml | In distribution | |
| HCLNH3 | Total Volume 4.5 ml | In distribution | |
| GH00HX | Total Volume 4.5 ml | 3 | In distribution |
| GH00NX | Total Volume 4.5 ml | 3 | In distribution |
| GH00N | Total Volume 9 ml | 6 | In distribution |
| GH00L | Total Volume 9 ml | 6 | In distribution |
| GH00H | Total Volume 9 ml | 6 | In distribution |
| SQC002 | Total Volume 10 ml | In distribution | |
| GH00S | Total Volume 4.5 ml | In distribution | |
| GH00LX | Total Volume 4.5 ml | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eurotrol | Eurotrol B.V. | 11 |
| CueSee® Co-OX | Eurotrol B.V. | 11 |
| Liquichek | Bio-Rad Laboratories Inc. | 8 |
| InteliQ | Bio-Rad Laboratories Inc. | 4 |
| Hemoglobin Test Strip | Urit Medical Electronic Co., Ltd. | 3 |
| HemoTrol Duo | Eurotrol B.V. | 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
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.