Identity
- Trade Name
- DG Gel 8 T/S Mono FDA UDI
- Generic Name
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210391 FDA UDI
- Description
- The DG Gel 8 T/S Mono card is for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. This test does not contain antibodies to complement components. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210391 FDA UDI
- Primary DI / UDI-DI
- 08437014205053 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
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
The DG Gel 8 T/S Mono card is a 2-3 paragraph in vitro diagnostic test for the determination of human A, B and D antigens on the surface of red blood cells, and for Indirect Antiglobulin Test of human blood samples. It does not contain antibodies to complement components and can be used with the DG Gel System, making it an ideal choice for routine testing.
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 611302aa-896e-4e7d-bcba-6c8a7135cd1e 36 fields · synced Jul 31, 2026