FLOW-COUNT 7547053

GUDID 15099590542450

Flow-Count Fluorospheres

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent
Primary Device ID15099590542450
NIH Device Record Keya1e996f9-1152-41dc-9407-7840f2794031
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOW-COUNT
Version Model Number7547053
Catalog Number7547053
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 Numbertrue
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
GS115099590542450 [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.

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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

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