Identity
- Trade Name
- QBC Diagnostics FDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- QBC STAR EUDAMEDQBC STAR-M Centrifugal Hematology System: QBC STAR-M Analyzer; QBC Disposable Starter Kit (20 STAR Tubes) FDA UDI
- Model / Reference
- 429001 EUDAMEDFDA UDI
- Description
- QBC STAR-M Centrifugal Hematology System: QBC STAR-M Analyzer; QBC Disposable Starter Kit (20 STAR Tubes) FDA UDI
Identifiers
- Catalog Number
- 429001 FDA UDI
- Primary DI / UDI-DI
- 00858092006000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858092006000 EUDAMED
- 510(k) Number
- K992849 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
- GMDN Term
- Full blood count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Austria 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
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
Yes
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Qbc Star by Drucker Diagnostics — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00858092006000 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | 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 5d628dda-6b39-434f-bc1f-a4cb3556a1de 61 fields · synced Jul 16, 2026
- FDA UDI 1a647fc7-ad87-4943-ac4f-df15a6a9b061 35 fields · synced May 30, 2026