Identity
- Trade Name
- Anti-Human Globulin Anti-C3d FDA UDI
- Generic Name
- Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody FDA UDI
- Device Name
- Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4. FDA UDI
- Model / Reference
- 210548 FDA UDI
- Description
- Anti-Human Globulin Anti-C3d (Murine Monoclonal) (12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with C3d components. Anti-Human Globulin Anti-C3d only recognizes the complement fragment and, consequently, cannot react with component C4. FDA UDI
Identifiers
- Catalog Number
- 210548 FDA UDI
- Primary DI / UDI-DI
- 23661562105483 FDA UDI
- GMDN Term
- Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody
Anti-Human Globulin Anti-C3d by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody.
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagast
Sources (1)
- FDA UDI b798d266-81e5-4860-8bc9-eed10e4ef648 35 fields · synced Jun 8, 2026