UDM (Urinalysis Data Manager) AB364503

GUDID 04987562488506

SYSMEX CORPORATION

Clinical laboratory information system
Primary Device ID04987562488506
NIH Device Record Key4a1c2ef9-7bd0-4337-b416-6def69f27e55
Commercial Distribution StatusIn Commercial Distribution
Brand NameUDM (Urinalysis Data Manager)
Version Model Number1.X
Catalog NumberAB364503
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Customer Support Contacts

Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562488506 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

Devices Manufactured by SYSMEX CORPORATION

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04987562518661 - Automated Blood Coagulation Analyzer CS-25002025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
04987562518678 - Automated Blood Coagulation Analyzer CA-600 series CA-6202025-09-19 A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use
04987562518685 - Automated Blood Coagulation Analyzer CA-600 series CA-6602025-09-19 a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.
04987562499687 - Automated Blood Coagulation Analyzer CN-60002025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator
04987562518630 - Automated Blood Coagulation Analyzer CN-60002025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator
04987562488506 - UDM (Urinalysis Data Manager)2025-03-24
04987562488506 - UDM (Urinalysis Data Manager)2025-03-24
04987562508440 - XQ-520 XQ-Series Automated Hematology Analyzer2025-01-22 The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic

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