STA® – Quality HNF/UFH
Catalogue number 00381, listed by Diagnostica Stago, Inc., 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
3510(k) clearances naming this product code
2recalls on this 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 | Diagnostica Stago, Inc., United States |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111822 |
| Record published | 2016-09-15 |
| Record revised | 2021-04-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00381 | 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 |
|---|---|
| K120014 | 2013-03-14 |
| K010324 | 2001-04-09 |
| K010350 | 2001-04-09 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-11-18 | Class II | Process control | A positive bias was confirmed to exists on the STA – Unicalibrator levels with STA – Deficient IX and STA – Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several Externa | 5,437 | 2023-01-12 |
| 2011-08-23 | Not classified | Nonconforming Material/Component | Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P. | 1259 units | 2013-09-04 |
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.