Identity
- Trade Name
- DG Gel 8 Direct Coombs FDA UDI
- Generic Name
- Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. For use with the DG Gel System. FDA UDI
- Model / Reference
- 210129 FDA UDI
- Description
- The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. For use with the DG Gel System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437014205909 FDA UDI
- GMDN Term
- Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination 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: Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
DG Gel 8 Direct Coombs 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 e333cede-a891-4281-a447-1f719e47506e 32 fields · synced May 30, 2026