Automated Blood Coagulation Analyzer CS-2100i

GUDID 04987562409471

CS-2100i COMPLETE

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory, automated
Primary Device ID04987562409471
NIH Device Record Key4ccd053f-29a5-446b-9b72-30be2c28f8ee
Commercial Distribution Discontinuation2016-09-29
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAutomated Blood Coagulation Analyzer CS-2100i
Version Model Number06372511
Company DUNS690664461
Company NameSYSMEX CORPORATION
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

Customer Support Contacts

Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562409471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-18
Device Publish Date2016-09-29

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
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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