Identity
- Trade Name
- BIOCLONE FDA UDI
- Generic Name
- Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody FDA UDI
- Device Name
- C3B C3D BIOCLONE 1X3ML FDA UDI
- Model / Reference
- 716540 FDA UDI
- Description
- C3B C3D BIOCLONE 1X3ML FDA UDI
Identifiers
- Catalog Number
- 716540 FDA UDI
- Primary DI / UDI-DI
- 10758750003570 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
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: Monospecific anti-complement component C3b/C3d (anti-C3b/anti-C3d) IVD, antibody
Bioclone by Ortho-Clinical Diagnostics — 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
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 2052b63a-0fda-42e2-a760-b002c7088d53 35 fields · synced Jun 8, 2026