Automated Blood Coagulation Analyzer CA-600 series

GUDID 04987562425686

Automated Blood Coagulation Analyzer CA-620

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory, automated
Primary Device ID04987562425686
NIH Device Record Keybff5d6d6-6c1e-40b6-ab4e-085f7a35df51
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomated Blood Coagulation Analyzer CA-600 series
Version Model NumberBR142626
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562425686 [Primary]

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 Number3
Public Version Date2018-09-18
Device Publish Date2016-08-04

On-Brand Devices [Automated Blood Coagulation Analyzer CA-600 series]

04987562425716Automated Blood Coagulation Analyzer CA-660
04987562425686Automated Blood Coagulation Analyzer CA-620

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