Identity
- Trade Name
- DG Gel 8 Anti-e FDA UDI
- Generic Name
- Anti-E [RH005] red blood cell grouping IVD, antibody FDA UDI
- Device Name
- For the determination of human e antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210124 FDA UDI
- Description
- For the determination of human e antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210124 FDA UDI
- Primary DI / UDI-DI
- 08437014205145 FDA UDI
- GMDN Term
- Anti-E [RH005] red blood cell grouping IVD, antibody 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 Anti-e 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 06fdf579-2eb1-4f90-997f-0134fb93e7ba 37 fields · synced May 30, 2026