Identity
- Trade Name
- QBC STAR Tube, 20 Test Kit EUDAMEDQBC Diagnostics FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Device Name
- QBC STAR Tube EUDAMEDQBC STAR Tube - Blood Collection Device (Bag of 20) FDA UDI
- Model / Reference
- 429011 EUDAMEDFDA UDI
- Description
- QBC STAR Tube - Blood Collection Device (Bag of 20) FDA UDI
Identifiers
- Catalog Number
- 429011 FDA UDI
- Primary DI / UDI-DI
- 00858092006376 EUDAMEDFDA UDI
- Basic UDI-DI
- 0858092006DDST2N EUDAMED
- Unit of Use DI
- 00858092006178 EUDAMED
- 510(k) Number
- K992849 FDA UDI
- FDA Product Code
- GKZ 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 II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QBC STAR Tube, 20 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 | 0858092006DDST2N | 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 611dd8b5-ddb6-4e44-8633-7f0647560cc2 61 fields · synced Sep 18, 2026
- FDA UDI 36718f36-e209-45df-b87c-7e53b5a781b8 35 fields · synced May 27, 2026