Plasma, Coagulation Control
Control 306-09POR Porc PUR/BLK 6L 10BX
3manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-29 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 2 to 10 °C; Special storage condition: Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable |
| Sizes | Total volume 5 ml |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 306-09POR | 10 | In distribution | |
| 550-11 | Total Volume 5.0 ml | In distribution | |
| 306-09POR | 10 | In distribution | |
| 550-11 | 0.1M CaCI2 | In distribution | |
| 550-11 | Total Volume 5.0 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| George King Pooled Normal Plasma | George King BIO-Medical, Inc. | 15 |
| directCHECK Whole Blood Controls | Accriva Diagnostics, Inc. | 12 |
| Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 8 |
| Lyphochek | Bio-Rad Laboratories Inc. | 8 |
| George King Single Donor Normal Plasma | George King BIO-Medical, Inc. | 7 |
| Validate | LGC Clinical Diagnostics, Inc. | 6 |
| George King Coumadin® Plasma | George King BIO-Medical, Inc. | 5 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| CueSee® Coag | Eurotrol B.V. | 5 |
| Rotem® | TEM Innovations GmbH | 4 |
| CRYOcheck™ Pooled Normal Plasma | Precision BioLogic Inc. | 4 |
| i-STAT | Abbott Point OF Care Inc. | 4 |
Showing 12 of 129. All products under Plasma, Coagulation Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103314 | 2010-12-03 |
| K103313 | 2010-12-01 |
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.