Synermed®
Serum Iron Reagent 1 X 250 mL + 1 X 80 mL
2manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Infrared Laboratory Systems LLC |
|---|---|
| FDA product code | CFM |
| Device type | Bathophenanthroline, Colorimetry, Iron (Non-Heme) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1410 |
| 510(k) | K912912 |
| Record published | 2016-09-20 |
| 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 | Storage environment temperature 0 to 4 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR320-X | In distribution | |
| IR320-WK | In distribution | |
| IR320-R | In distribution | |
| IR321-L | In distribution | |
| IR320-911 | In distribution | |
| IR322-L | In distribution | |
| IR320-1200 | In distribution |
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.