Automated Blood Coagulation Analyzer CA-600 series CA-660 CK978289

GUDID 04987562518685

a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory

• Primary Device ID: 04987562518685
• NIH Device Record Key: 99009901-95df-40cd-b766-276ce3f15598
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Blood Coagulation Analyzer CA-600 series CA-660
• Version Model Number: CA174898
• Catalog Number: CK978289
• 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)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562518685 [Primary]

FDA Product Code

• GKP: INSTRUMENT, COAGULATION, AUTOMATED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-19
• Device Publish Date: 2024-02-22

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: 2025-09-19a 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