Iron (Fe)
2 catalogue numbers from SI8049, listed by Randox Laboratories Limited, United Kingdom, under Ferrozine (Colorimetric) Iron Binding Capacity. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | JMO |
| Device type | Ferrozine (Colorimetric) Iron Binding Capacity |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1415 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
|---|---|---|
| SI8049 | In distribution | |
| SI8330 | 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 |
| Direct Tibc Reagent | Medtest DX | 1 |
| AU | Beckman Coulter, Inc. | 1 |
Showing 12 of 29. All products under Ferrozine (Colorimetric) Iron Binding Capacity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K974604 | 1998-01-06 |
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.