Identity
- Trade Name
- DG Gel 8 Anti-IgG (Rabbit) FDA UDI
- Generic Name
- Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody FDA UDI
- Device Name
- The DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210394 FDA UDI
- Description
- The DG Gel 8 Anti-IgG (Rabbit) card is for the Direct and Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210394 FDA UDI
- Primary DI / UDI-DI
- 08437014205060 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
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
Yes
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: Monospecific immunoglobulin G antihuman globulin (IgG AHG) IVD, antibody
DG Gel 8 Anti-IgG (Rabbit) by Diagnostic Grifols Sa — 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
- Diagnostic Grifols Sa
Sources (1)
- FDA UDI d25e31d7-9bdf-496e-9b4a-c8df2a715919 35 fields · synced Jun 8, 2026