Identity
- Trade Name
- DG Gel 8 ABO/Rh FDA UDI
- Generic Name
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 ABO/Rh card is for the determination of ABO forward and reverse group and D antigen on the surface of red blood cells, and for ABO Compatibility Test in human blood samples. For use with Manual Method. Not for use with Erytra or WADiana Compact. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210118 FDA UDI
- Description
- The DG Gel 8 ABO/Rh card is for the determination of ABO forward and reverse group and D antigen on the surface of red blood cells, and for ABO Compatibility Test in human blood samples. For use with Manual Method. Not for use with Erytra or WADiana Compact. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210118 FDA UDI
- Primary DI / UDI-DI
- 08437014205077 FDA UDI
- GMDN Term
- ABO/Rh 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 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 b2173fec-693d-4b4b-b17b-25fbc2683554 37 fields · synced May 30, 2026