XQ-320 XQ-Series Automated Hematology Analyzer

Basic Information

• Brand Name: XQ-320 XQ-Series Automated Hematology Analyzer
• Primary DI: 04987562503131
• Version / Model: BU954129
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-24
• Public Version: 1
• Public Version Date: 2024-06-03
• Public Version Status: New
• Public Device Record Key: 511acb20-1bea-4c80-8059-701bf241f635

Device Description

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 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, R DW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKZ	Counter, Differential Cell	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35476	Haematological cell analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987562503131	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]