Primary Device ID | 04987562425426 |
NIH Device Record Key | 77a044b9-856c-46bd-8285-e12da54f938e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Automated Blood Coagulation Analyzer CS-5100 |
Version Model 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 |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 04987562425426 [Primary] |
JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-09-18 |
Device Publish Date | 2016-08-05 |
04987562425426 | CS-5100 COMPLETE |
04987562518654 | A fully automated blood coagulation analyzer intended for in vitro diagnostic use. |