Berichrom® Plasminogen
Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Siemens Healthcare Diagnostics Products GmbH, Germany |
|---|---|
| FDA product code | DDX |
| Device type | Plasminogen, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5715 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K884766 |
| Record published | 2020-09-24 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10446431 | In distribution | |
| 10873885 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| STA® – Stachrom® Plasminogen | Diagnostica Stago, Inc. | 1 |
| Human Plasminogen ’NL’ Bindarid™ Radial Immunodiffusion Kit | The Binding Site Group Ltd. | 1 |
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.