Biophen Lmwh Control Plasma
Catalogue number 223001, listed by Hyphen Biomed, United States, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | Hyphen Biomed, United States |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| 510(k) | K051472 |
| Record published | 2016-08-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 223001 | 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 |
| Plasma, Coagulation Control | Medtronic, 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 |
Showing 12 of 129. All products under Plasma, Coagulation Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051472 | 2005-12-23 |
| K043451 | 2005-03-17 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aniara Diagnostica, LLC | 510(k) number | 2022-06-28 | Class III | Under Investigation by firm | Incorrect product labeling was included in the package. | 13 units (1 unit is 1 box) | 2024-04-18 |
| Aniara Diagnostica, LLC | 510(k) number | 2019-03-19 | Class III | Error in labeling | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | 14 kits | 2019-07-12 |
| Aniara Diagnostica, LLC | 510(k) number | 2019-03-19 | Class III | Error in labeling | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | 41 units | 2019-07-12 |
| Aniara Diagnostica, LLC | 510(k) number | 2019-03-19 | Class III | Error in labeling | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | 3 units | 2019-07-12 |
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.