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QBC Capillary Blood Tube, 100 Test Kit
EUDAMEDFDA UDIClass A (EU MDR)
Ref 424241
Identity
- Trade Name
- QBC Capillary Blood Tube, 100 Test Kit EUDAMEDQBC Diagnostics FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Device Name
- QBC Capillary Blood Tube EUDAMEDCapillary Tube - Blood Collection Device (100 Test Kit) FDA UDI
- Model / Reference
- 424241 EUDAMEDFDA UDI
- Description
- Capillary Tube - Blood Collection Device (100 Test Kit) FDA UDI
Identifiers
- Catalog Number
- 424241 FDA UDI
- Primary DI / UDI-DI
- 00858092006420 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858092006DDCTZ3 EUDAMED
- Unit of Use DI
- 00858092006352 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 Capillary 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 | 0858092006DDCTZ3 | 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 0c11a397-a088-4245-9f6a-ce3532081224 61 fields · synced Jul 15, 2026
- FDA UDI d696ead6-a5da-41f3-98e6-cf61eb538dea 34 fields · synced May 30, 2026