Duns Number:690664461
Device Description: Automated Hematology Analyzer XN-L series XN-450
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
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
GKZ
Product Code Name
Counter, differential cell
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 50 |