Catalog Number

-

Brand Name

Automated Hematology Analyzer XE-2100D

Version/Model Number

03309313

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K992875

Product Code

GKZ

Product Code Name

Counter, differential cell

Public Device Record Key

32c59f4a-3112-4947-937d-d3f37eb34d10

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

February 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-