George King Multi-Coumadin® Kit is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative…
George King Multi-Coumadin® Kit is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
Record
Regulatory record for George King Multi-Coumadin® Kit | Listed by | George King BIO-Medical, Inc., United States |
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
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: -70˚C or below |
| Distribution end date | 2017-01-23 |
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.