Identity
- Trade Name
- Anti-Human Globulin Anti-IgG FDA UDI
- Generic Name
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
- Device Name
- Anti-Human Globulin, Anti-IgG, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin, Anti-IgG, is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG. FDA UDI
- Model / Reference
- Z356U FDA UDI
- Description
- Anti-Human Globulin, Anti-IgG, is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG. Anti-Human Globulin, Anti-IgG, is intended for use in the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060242471629 FDA UDI
- GMDN Term
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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 immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
Anti-Human Globulin Anti-IgG by Alba Bioscience Limited — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Alba Bioscience Limited
Sources (1)
- FDA UDI 15b8b284-df16-4861-bf0c-eafac1509733 34 fields · synced May 30, 2026