Identity
- Trade Name
- Anti-Human Globulin Anti-IgG,-C3d, polyspecific - Green FDA UDI
- Generic Name
- Polyspecific antihuman globulin/complement IVD, antibody FDA UDI
- Device Name
- Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement FDA UDI
- Model / Reference
- 210546 FDA UDI
- Description
- Anti-Human Globulin Anti-IgG,-C3d (Murine Monoclonal) (18833+18896+12011D10) is intended for use in the direct antiglobulin test to detect the in vivo coating on human red blood cells with IgG and/or C3d components. In addition to recognizing IgG antibodies and the complement fragment C3d, Anti Human Globulin Anti-IgG, C3d is able to recognize IgM antibodies on the surface of red blood cells since IgM antibodies always fix complement FDA UDI
Identifiers
- Catalog Number
- 210546 FDA UDI
- Primary DI / UDI-DI
- 23661562105469 FDA UDI
- GMDN Term
- Polyspecific antihuman globulin/complement 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: Polyspecific antihuman globulin/complement IVD, antibody
Anti-Human Globulin Anti-IgG, -C3d, polyspecific - Green by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyspecific antihuman globulin/complement IVD, antibody.
- Anti-Human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal (Green) — ALBA BIOSCIENCE LIMITED
- Anti-Human-Globulin, Anti-IgG — Bio-Rad Medical Diagnostics GmbH
- IH-Card AHG Anti-IgG, -C3d — Bio-Rad Medical Diagnostics GmbH
- IH-Card AHG Anti-IgG, -C3d — Bio-Rad Medical Diagnostics GmbH
- Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific — Bio-Rad Medical Diagnostics GmbH
- IH-Card AHG Anti-IgG, -C3d — Bio-Rad Medical Diagnostics GmbH
- Anti-human Globulin Anti-IgG, -C3d Polyspecific Rabbit/Murine Monoclonal — ALBA BIOSCIENCE LIMITED
- Anti-Human Globulin Anti-IgG, -C3d, polyspecific - Clear — DIAGAST
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
- Diagast
Sources (1)
- FDA UDI 0287a2a8-8603-4b64-97d6-fe678bab1cb2 35 fields · synced Jun 8, 2026