Identity
- Trade Name
- DG Gel 8 ABO/Rh (2D) FDA UDI
- Generic Name
- ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples. For use with the DG Gel System. FDA UDI
- Model / Reference
- 210128 FDA UDI
- Description
- The DG Gel 8 ABO/Rh (2D) card is for the determination of ABO forward and reverse group, and RhD antigen on the surface of red blood cells of human blood samples. For use with the DG Gel System. FDA UDI
Identifiers
- Catalog Number
- 210128 FDA UDI
- Primary DI / UDI-DI
- 08437014205916 FDA UDI
- GMDN Term
- ABO/Rh(D)/Kell multiple blood grouping 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
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
Category: ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination
DG Gel 8 ABO/Rh (2D) by Diagnostic Grifols Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ABO/Rh(D)/Kell multiple blood grouping IVD, kit, agglutination.
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 fbd4a1b9-da5d-4ac5-8338-d2117d924137 36 fields · synced May 31, 2026