Human Plasminogen ’NL’ Bindarid™ Radial Immunodiffusion Kit
Catalogue number RN065.3, listed by The Binding Site Group Ltd., United Kingdom, under Plasminogen, Antigen, Antiserum, Control. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
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 | The Binding Site Group Ltd., United Kingdom |
|---|---|
| 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) | K941346 |
| Record published | 2016-09-24 |
| Record revised | 2026-01-23 (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 |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RN065.3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Berichrom® Plasminogen | Siemens Healthcare Diagnostics Products GmbH | 2 |
| STA® – Stachrom® Plasminogen | Diagnostica Stago, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K941346 | 1994-09-09 |
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.