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Refurbished QBC Autoread Plus Dry Hematology Analyzer
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 42957609
Identity
- Trade Name
- QBC Diagnostics FDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- Refurbished QBC Autoread Plus Dry Hematology Analyzer EUDAMEDFDA UDI
- Model / Reference
- 42957609 EUDAMEDFDA UDI
- Description
- Refurbished QBC Autoread Plus Dry Hematology Analyzer FDA UDI
Identifiers
- Catalog Number
- 42957609 FDA UDI
- Primary DI / UDI-DI
- 00858092006086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00858092006086 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Refurbished QBC Autoread Plus Dry Hematology Analyzer by Drucker Diagnostics — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00858092006086 | 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 5087a0bc-e4bd-4737-bbef-c20ef350f3b9 61 fields · synced Jun 18, 2026
- FDA UDI 37dc0b29-5bf9-4db0-9b2a-9de5c3a4b69c 35 fields · synced May 30, 2026