Identity
- Trade Name
- IH-Card AHG Anti-IgG FDA UDI
- Generic Name
- Polyspecific antihuman globulin IVD, antibody FDA UDI
- Device Name
- Anti-Human Globulin Anti-IgG; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 12 cards of 6 microtubes FDA UDI
- Model / Reference
- 813420100 FDA UDI
- Description
- Anti-Human Globulin Anti-IgG; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 12 cards of 6 microtubes FDA UDI
Identifiers
- Catalog Number
- 813420100 FDA UDI
- Primary DI / UDI-DI
- 07611969964840 FDA UDI
- GMDN Term
- Polyspecific antihuman globulin 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
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyspecific antihuman globulin IVD, antibody
IH-Card AHG Anti-IgG by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyspecific antihuman globulin 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
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI ab4c0fc1-0f36-4254-9f2f-5db5411321af 35 fields · synced Jun 8, 2026