e-CHECK

GUDID 14987562460288

E-Check 4X4.5MLX3 Low/Normal/High

SYSMEX CORPORATION

Full blood count IVD, control

• Primary Device ID: 14987562460288
• NIH Device Record Key: bc57689f-075d-4890-80bf-6a54fa77a736
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-CHECK
• Version Model Number: 199-4004-1
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Dimensions

• Total Volume: 4.5 Milliliter
• Total Volume: 4.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	14987562460288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K994388

FDA Product Code

• JPK: MIXTURE, HEMATOLOGY QUALITY CONTROL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-18
• Device Publish Date: 2016-08-05

Devices Manufactured by SYSMEX CORPORATION

• 04987562518654 - Automated Blood Coagulation Analyzer CS-5100: 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
• 04987562518661 - Automated Blood Coagulation Analyzer CS-2500: 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
• 04987562518678 - Automated Blood Coagulation Analyzer CA-600 series CA-620: 2025-09-19 A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use
• 04987562518685 - Automated Blood Coagulation Analyzer CA-600 series CA-660: 2025-09-19 a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.
• 04987562499687 - Automated Blood Coagulation Analyzer CN-6000: 2025-09-01 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-6000: 2025-09-01 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 Analyzer: 2025-01-22 The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic