Automated Blood Coagulation Analyzer CN-6000 CV339763

GUDID 04987562518630

The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory

• Primary Device ID: 04987562518630
• NIH Device Record Key: 9cda2a67-cd33-4e2d-bf4c-b6dfb8056c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Blood Coagulation Analyzer CN-6000
• Version Model Number: AX801645
• Catalog Number: CV339763
• 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

Customer Support Contacts

• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com
• Phone: +1(888)879-7644
• Email: crc@sysmex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562518630 [Primary]

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [Automated Blood Coagulation Analyzer CN-6000]

• 04987562518630: The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnost
• 04987562499687: The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnost