Automated Blood Coagulation Analyzer CS-5100 BY990757

GUDID 04987562518654

Coagulation analyser IVD, laboratory

Primary Device ID	04987562518654
NIH Device Record Key	eb52c904-2dde-40f0-ab2e-f34c525805d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Automated Blood Coagulation Analyzer CS-5100
Version Model Number	CU624138
Catalog Number	BY990757
Company DUNS	690664461
Company Name	SYSMEX CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	04987562518654 [Primary]

JPA	SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Steralize Prior To Use	false
Device Is Sterile	false

04987562425426	CS-5100 COMPLETE
04987562518654	A fully automated blood coagulation analyzer intended for in vitro diagnostic use.