DxH 900 Hematology System

GUDID 15099590701574

UniCel DxH 900 Coulter Cellular Analysis System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated
Primary Device ID15099590701574
NIH Device Record Keyea97262c-d4b5-44e3-80d8-f5bc2fb0a5a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDxH 900 Hematology System
Version Model NumberC11478
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590701574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-23
Device Publish Date2018-05-03

Devices Manufactured by Beckman Coulter, Inc.

15099590762889 - Stem-Kit Reagents2024-11-04 Stem-Kit Reagents
15099590762896 - StemTrol Control Cells2024-11-04 StemTrol Control Cells
15099590732103 - DxI 9000 Access Immunoassay Analyzer2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali
15099590575243 - Access hLH2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
15099590760823 - Access NT-proBNP2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
15099590760830 - ACCESS NT-proBNP CALIBRATORS2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
15099590772840 - Access Ferritin2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
15099590745158 - ACCESS HIV Ag/Ab combo2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.