Automated Hematology Analyzer XN-L series XN-450 - Automated Hematology Analyzer XN-L series XN-450 - SYSMEX CORPORATION

Duns Number:690664461

Device Description: Automated Hematology Analyzer XN-L series XN-450

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More Product Details

Catalog Number

-

Brand Name

Automated Hematology Analyzer XN-L series XN-450

Version/Model Number

BM392756

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GKZ

Product Code Name

Counter, differential cell

Device Record Status

Public Device Record Key

8ad36076-900c-46d6-a2fe-f833684154b2

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

February 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYSMEX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50