Identity
- Trade Name
- DG Gel 8 ABO/Rh+Kell FDA UDI
- Generic Name
- ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of human blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210383 FDA UDI
- Description
- The DG Gel 8 ABO/Rh + Kell card is for the determination of ABO forward and reverse group, and D and K antigens on the surface of red blood cells of human blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210383 FDA UDI
- Primary DI / UDI-DI
- 08437014205015 FDA UDI
- GMDN Term
- ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- Commercial Distribution
- Not 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
HCT/P
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
DG Gel 8 ABO/Rh+Kell by Diagnostic Grifols Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 678b5cb7-d247-42af-b321-ae10c85fc853 37 fields · synced May 30, 2026