STA® – Stachrom® Plasminogen
Catalogue number 00658, listed by Diagnostica Stago, Inc., United States, under Plasminogen, Antigen, Antiserum, Control. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
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 | Diagnostica Stago, Inc., United States |
|---|---|
| FDA product code | DDX |
| Device type | Plasminogen, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5715 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K832591 |
| Record published | 2016-09-15 |
| Record revised | 2021-05-03 (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 |
|---|---|---|
| 00658 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Berichrom® Plasminogen | Siemens Healthcare Diagnostics Products GmbH | 2 |
| 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.