George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated…
George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
Record
Regulatory record for George King Single Donor Normal Plasma | 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 | 2016-08-21 |
| Record revised | 2026-05-18 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: -70˚C or below |
| Distribution end date | 2023-04-01 |
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.