Identity
- Trade Name
- DG Gel Essential Control FDA UDI
- Generic Name
- Multiple immunohaematology test IVD, control FDA UDI
- Device Name
- DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for: (i) the determination of the ABO, Rh and K antigens; (ii) the determination of the appropriate ABO blood group antibodies; and (iii) the detection of unexpected antibodies. For use with DG Gel 8 technique. For in vitro diagnostic use. FDA UDI
- Model / Reference
- 2x2x6ml FDA UDI
- Description
- DG Gel Essential Control is intended to allow regular quality control of materials, work procedures and instrument procedures for: (i) the determination of the ABO, Rh and K antigens; (ii) the determination of the appropriate ABO blood group antibodies; and (iii) the detection of unexpected antibodies. For use with DG Gel 8 technique. For in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 213288 FDA UDI
- Primary DI / UDI-DI
- 07640137341381 FDA UDI
- GMDN Term
- Multiple immunohaematology test IVD, control FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Multiple immunohaematology test IVD, control
DG Gel Essential Control by Medion Grifols Diagnostics AG — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple immunohaematology test IVD, control.
- Checkcell (Weak) — IMMUCOR, INC. · Class II
- Checkcell — IMMUCOR, INC. · Class II
- Checkcell (Weak) — IMMUCOR, INC. · Class II
- Monoclonal Control — IMMUCOR, INC. · Class II
- Gamma-clone Control — IMMUCOR, INC. · Class II
- corQC EXTEND Complete — IMMUCOR, INC. · Class II
- Monoclonal Control — IMMUCOR, INC. · Class II
- DAT Positive Control Cell — IMMUCOR, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medion Grifols Diagnostics AG
Sources (1)
- FDA UDI 0d72676d-5c4e-4c36-8928-f41d4b4bfea8 34 fields · synced Jun 1, 2026