George King B-FACT is a borderline abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of…
George King B-FACT is a borderline abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
Record
Regulatory record for George King B-Fact | 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 |
| 510(k) | K945854 |
| Record published | 2016-08-17 |
| Record revised | 2026-05-18 (version 6) |
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.