uTASWako DCP 995-60701

GUDID 00856626006120

In-Vitro Diagnostic Use

WAKO LIFE SCIENCES, INC.

Des-gamma-carboxyprothrombin (DCP) IVD, reagent

• Primary Device ID: 00856626006120
• NIH Device Record Key: 69f014f8-f2a2-4660-8e44-8b0ed4958225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uTASWako DCP
• Version Model Number: 995-60701
• Catalog Number: 995-60701
• Company DUNS: 078629716
• Company Name: WAKO LIFE SCIENCES, INC.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856626006120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• OAU: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-07

Devices Manufactured by WAKO LIFE SCIENCES, INC.

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• 00856626006106 - Autokit Micro Albumin Calibrator Set: 2018-07-06 In-Vitro Diagnostic Use
• 00856626006113 - Autokit CH50: 2018-07-06 In-Vitro Diagnostic Use
• 00856626006120 - uTASWako DCP: 2018-07-06In-Vitro Diagnostic Use
• 00856626006120 - uTASWako DCP: 2018-07-06 In-Vitro Diagnostic Use
• 00856626006151 - CH50 Calibrator: 2018-07-06 In-Vitro Diagnostic Use
• 00856626006205 - uTASWako AFP-L3: 2018-07-06 In-Vitro Diagnostic Use
• 00856626006212 - μTASWako DCP Calibrator Set: 2018-07-06 In-Vitro Diagnostic Use
• 00085662006168 - μTASWako AFP-L3 Calibrator Set: 2018-07-06 In-Vitro Diagnostic Use