Identity
- Trade Name
- DG Gel 8 Rh Pheno FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 210228 FDA UDI
- Description
- The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two separate blood samples. For use with the DG Gel System. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 210228 FDA UDI
- Primary DI / UDI-DI
- 08436583731093 FDA UDI
- GMDN Term
- Rhesus (Rh) phenotype (CcDEe) 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: Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination
DG Gel 8 Rh Pheno by Diagnostic Grifols Sa — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination.
- LT Rh Phenotype Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- MTS — MICRO TYPING SYSTEMS, INC
- LT Rh Phenotype Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- DG Gel 8 Anti-E — DIAGNOSTIC GRIFOLS SA
- DG Gel 8 Anti-c — DIAGNOSTIC GRIFOLS SA
- DG Gel 8 Anti-C — DIAGNOSTIC GRIFOLS SA
- DG Gel 8 Anti-e — DIAGNOSTIC GRIFOLS SA
- DG Gel 8 Anti-D — DIAGNOSTIC GRIFOLS SA
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 df08b040-fc6d-402b-985f-4970c5a9eb63 36 fields · synced May 30, 2026