BC-3200 Hematology Analyzer

Basic Information

• Brand Name: BC-3200 Hematology Analyzer
• Primary DI: 06944904002422
• Version / Model: BC-3200
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Labeler DUNS: 654671304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-17
• Public Version: 2
• Public Version Date: 2026-01-20
• Public Version Status: Update
• Public Device Record Key: 16af29bd-c8e5-45d9-8406-7999da5827ca

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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	06944904002422	GS1

Premarket Submissions

Submission Number	Supplement Number
K093394	000