Identity
- Trade Name
- QBC Venous Blood Tube, 100 Test Kit EUDAMEDQBC Diagnostics FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Device Name
- QBC Venous Blood Tube EUDAMEDVenous Tube - Blood Collection Device (100 Test Kit) FDA UDI
- Model / Reference
- 424240 EUDAMEDFDA UDI
- Description
- Venous Tube - Blood Collection Device (100 Test Kit) FDA UDI
Identifiers
- Catalog Number
- 424240 FDA UDI
- Primary DI / UDI-DI
- 00858092006390 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858092006DDVT2X EUDAMED
- Unit of Use DI
- 00858092006369 EUDAMED
- FDA Product Code
- GIO FDA UDI
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED
- GMDN Term
- Capillary blood collection tube IVD, K2EDTA FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- 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
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
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QBC Venous Blood Tube, 100 Test Kit by Drucker Diagnostics — 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 | 0858092006DDVT2X | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Drucker Diagnostics
- EUDAMED SRN
- US-MF-000031517
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 68345d33-5d2b-49ba-8578-21c27b86bab7 61 fields · synced Jul 18, 2026
- FDA UDI dbae4148-c8e4-464c-89b4-4a39e4ef3fb2 34 fields · synced May 30, 2026