T-TAS 01 Total Thrombus Formation Analysis System 18001

GUDID 04589448510013

System to analyze thrombus formation under blood flow conditions using disposable microchips.

ZACROS CORPORATION

Platelet aggregation analyser IVD

• Primary Device ID: 04589448510013
• NIH Device Record Key: 9f738a6b-c643-4567-89af-2c03968b9624
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-TAS 01 Total Thrombus Formation Analysis System
• Version Model Number: T-TAS 01-1
• Catalog Number: 18001
• Company DUNS: 690584370
• Company Name: ZACROS 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: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04589448510013 [Primary]
GS1	04589448510020 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191364

FDA Product Code

• JOZ: System, Automated Platelet Aggregation

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: 2024-12-16
• Device Publish Date: 2024-12-06

Devices Manufactured by ZACROS CORPORATION

• 04589448510037 - PL Chip for T-TAS 01: 2024-12-20 Flow chamber microchip used to measure platelet thrombus formation (primary hemostatic function), 20 chips
• 04589448510044 - PL Chip Reservoir Set for T-TAS 01: 2024-12-20 Disposable accessories for use with the PL Chip for T-TAS 01, 100 sets
• 04589448510051 - BAPA tube for T-TAS 01: 2024-12-20 Blood collection tube containing BAPA anticoagulant for use with the PL Chip for T-TAS 01, 50/pack
• 14589448510089 - PL Chip: 2024-12-20 Flow chamber microchip used to measure platelet thrombus formation (primary hemostatic function)
• 14589448510096 - PL Chip Reservoir Set: 2024-12-20 Disposable accessories for use with the PL Chip
• 14589448510102 - BAPA tube: 2024-12-20 Blood collection tube containing BAPA anticoagulant for use with the PL Chip
• 04589448510013 - T-TAS 01 Total Thrombus Formation Analysis System: 2024-12-16System to analyze thrombus formation under blood flow conditions using disposable microchips.
• 04589448510013 - T-TAS 01 Total Thrombus Formation Analysis System: 2024-12-16 System to analyze thrombus formation under blood flow conditions using disposable microchips.