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XQ-520 XQ-Series Automated Hematology Analyzer
FDA UDIClass II (US FDA UDI)
by Sysmex Corp.
Identity
- Trade Name
- XQ-520 XQ-Series Automated Hematology Analyzer FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-520 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/# FDA UDI
- Model / Reference
- AJ968479 FDA UDI
- Description
- The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-520 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/# FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987562508440 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Haematological cell analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Category: Haematological cell analyser IVD
XQ-520 XQ-Series Automated Hematology Analyzer by Sysmex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corp.
Sources (1)
- FDA UDI 44e1e773-ae67-4f9b-acb1-4cb207876a6d 34 fields · synced Jun 6, 2026