Haemoglobin F AND A2 Controls – Level 1 AND 2 (Hb F & A2 Control)
Catalogue number HA5083, listed by Randox Laboratories Limited, United Kingdom, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HA5083 | 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 |
| 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 |
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.