Iron (Fe) Reagent Kit
Iron Reagent Kit for use with EasyRA Analyzers
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Medica Corp., United States |
|---|---|
| FDA product code | JMO |
| Device type | Ferrozine (Colorimetric) Iron Binding Capacity |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1415 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K080810 |
| Record published | 2019-02-14 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10223-4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synermed® | Infrared Laboratory Systems LLC | 5 |
| Fe | Randox Laboratories Limited | 4 |
| Uibc-SL | Sekisui Diagnostics, LLC | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 3 |
| Synchron | Beckman Coulter, Inc. | 3 |
| Total Iron-Binding Capacity 2 (TIBC_2) | Randox Laboratories Limited | 3 |
| Iron (Total) | Sekisui Diagnostics, LLC | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| K-Assay® Uibc Reagent | Kamiya Biomedical Company LLC | 2 |
| Total-Iron Binding Capacity (Tibc) | Randox Laboratories Limited | 2 |
| Iron (Fe) | Randox Laboratories Limited | 2 |
| Direct Tibc Reagent | Medtest DX | 1 |
Showing 12 of 29. All products under Ferrozine (Colorimetric) Iron Binding Capacity
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.