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ConcizuTrace™ Sample Collection Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref CZM10596
Identity
- Trade Name
- ConcizuTrace™ Sample Collection Kit EUDAMEDFDA UDI
- Generic Name
- Venous blood collection kit IVD FDA UDI
- Device Name
- ConcizuTrace™ Sample Collection Kit EUDAMEDThe Randox ConcizuTrace™ sample collection kit is used for the collection and transportation of blood samples, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing using either the ConcizuTrace™ ELISA kit or Concizumab ELISA kit. FDA UDI
- Model / Reference
- CZM10596 EUDAMEDFDA UDI
- Description
- The Randox ConcizuTrace™ sample collection kit is used for the collection and transportation of blood samples, taken by a trained phlebotomist. The samples will be transported to a professional laboratory for testing using either the ConcizuTrace™ ELISA kit or Concizumab ELISA kit. FDA UDI
Identifiers
- Catalog Number
- CZM10596 FDA UDI
- Primary DI / UDI-DI
- 05055273218893 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732ACTSCKT047KQ EUDAMED
- FDA Product Code
- PQD FDA UDI
- EMDN Code
- W0501010199 VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Venous blood collection kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ConcizuTrace™ Sample Collection Kit by Randox Laboratories Limited — Class A — 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 | 50552732ACTSCKT047KQ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 75137661-4822-450a-a179-6d9c928fe0c7 61 fields · synced Jun 19, 2026
- FDA UDI d22b8000-6095-4582-bf30-9022207a3a75 36 fields · synced May 30, 2026