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Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit FDA UDI
- Generic Name
- Plasminogen IVD, kit, precipitation/immunodiffusion FDA UDI
- Model / Reference
- RN065.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700010764 FDA UDI
- 510(k) Number
- K941346 FDA UDI
- FDA Product Code
- DDX FDA UDI
- GMDN Term
- Plasminogen IVD, kit, precipitation/immunodiffusion FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5715 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Plasminogen IVD, kit, precipitation/immunodiffusion
Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI c6fd29ea-5dd5-4540-8dad-f47f298b5a13 35 fields · synced May 30, 2026