Identity
- Trade Name
- ConcizuTrace™ ELISA EUDAMEDFDA UDI
- Generic Name
- Concizumab therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ConcizuTrace™ ELISA EUDAMEDThe ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals. FDA UDI
- Model / Reference
- CZM10591 EUDAMEDFDA UDI
- Description
- The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals. FDA UDI
Identifiers
- Catalog Number
- CZM10591 FDA UDI
- Primary DI / UDI-DI
- 05055273218985 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732CCELISA0649X EUDAMED
- 510(k) Number
- DEN240035 FDA UDI
- FDA Product Code
- SES FDA UDI
- EMDN Code
- W01020899 THERAPEUTIC DRUG MONITORING - OTHER EUDAMED
- GMDN Term
- Concizumab therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7298 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
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
ConcizuTrace™ ELISA by Randox Laboratories Limited — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732CCELISA0649X | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED a6e463bf-f18b-499f-a74a-d0232b10e14b 61 fields · synced Jul 23, 2026
- FDA UDI 8d9de463-c8c6-4980-9045-3817769c2491 37 fields · synced May 27, 2026