Uibc
The product is intended for the quantitative in vitro determination of Iron/UIBC in serum.
2manufacturers in China registered for this device type
1catalogue number
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 |
| 510(k) | K974604 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: R2. Stable for 4 weeks at +2 to +8°C. R4. Stable for 6 months at +15 to +25°C. All other reagents are ready for use as s; Storage environment temperature 15 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SI250 | 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
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.