CS/CC B4-RD1 6603846

GUDID 15099590542375

CYTO-STAT/COULTER CLONE B4-RD1

Beckman Coulter, Inc.

Multiple CD cell marker IVD, antibody
Primary Device ID15099590542375
NIH Device Record Key09446b5f-b33c-4054-a867-0aa79e663de1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS/CC B4-RD1
Version Model Number6603846
Catalog Number6603846
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590542375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Beckman Coulter, Inc.

05099590798218 - DxH2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590209636 - DxH2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.