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QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 428605
Identity
- Trade Name
- QBC Diagnostics FDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge EUDAMEDFDA UDI
- Model / Reference
- 428605 EUDAMEDFDA UDI
- Description
- QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge FDA UDI
Identifiers
- Catalog Number
- 428605 FDA UDI
- Primary DI / UDI-DI
- 00858092006048 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858092006048 EUDAMED
- 510(k) Number
- K960827 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
- Northern Ireland 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
No
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 Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge by Drucker Diagnostics — Class IVD General — IVDD, FDA UDI — listed in…
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-00858092006048 | 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 29bb7da0-192c-4e9e-98b0-28fca5168f01 61 fields · synced Jun 18, 2026
- FDA UDI f95d244a-b8f1-42cc-ad18-54c80137fb93 35 fields · synced May 30, 2026