| Primary Device ID | 04987562508440 | 
| NIH Device Record Key | 44e1e773-ae67-4f9b-acb1-4cb207876a6d | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | XQ-520 XQ-Series Automated Hematology Analyzer | 
| Version Model Number | AJ968479 | 
| Company DUNS | 690664461 | 
| Company Name | SYSMEX CORPORATION | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
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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%/# | 
| 04987562508440 - XQ-520 XQ-Series Automated Hematology Analyzer | 2025-01-22 The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic |