Primary Device ID | 04987562518661 |
NIH Device Record Key | db6d9db6-7ef3-45cf-932a-a13065fc273f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Automated Blood Coagulation Analyzer CS-2500 |
Version Model Number | AG528355 |
Catalog Number | BV981798 |
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 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com | |
Phone | +1(888)879-7639 |
crc@sysmex.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987562518661 [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 | 2 |
Public Version Date | 2025-09-19 |
Device Publish Date | 2024-02-22 |
04987562433735 | CS-2500 COMPLETE |
04987562518661 | A fully automated blood coagulation analyzer intended for in vitro diagnostic use. |