Identity
- Trade Name
- FITC Anti-Rabies Monoclonal Globulin FDA UDI
- Generic Name
- Rabies virus antigen IVD, antibody FDA UDI
- Model / Reference
- 800-092 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850212007003 FDA UDI
- FDA Product Code
- GOI FDA UDI
- GMDN Term
- Rabies virus antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3460 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: Rabies virus antigen IVD, antibody
FITC Anti-Rabies Monoclonal Globulin by Fujirebio Diagnostics AB — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Fujirebio Diagnostics AB
Sources (1)
- FDA UDI c26056a8-9807-474a-a39f-c8fefdf7c213 35 fields · synced Jun 8, 2026