Identity
- Trade Name
- Anti-C3b,-C3d (Murine Monoclonal) Gamma-clone FDA UDI
- Generic Name
- Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody FDA UDI
- Device Name
- This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial. FDA UDI
- Model / Reference
- 0004068 FDA UDI
- Description
- This reagent is used in direct antiglobulin tests where the detection of C3 (as C3b or C3d) is required. This product configuration is a single vial. FDA UDI
Identifiers
- Catalog Number
- 0004068 FDA UDI
- Primary DI / UDI-DI
- 10888234000402 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody
Anti-C3b, -C3d (Murine Monoclonal) Gamma-clone by Immucor, Inc. — 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 |
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Manufacturer
- Manufacturer
- Immucor, Inc.
Sources (1)
- FDA UDI b63a2a93-aa01-4ec0-886b-a10e29422d56 36 fields · synced Jun 8, 2026