μTASWako AFP-L3 Calibrator Set 997-60901

GUDID 00085662006168

In-Vitro Diagnostic Use

WAKO LIFE SCIENCES, INC.

Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator

• Primary Device ID: 00085662006168
• NIH Device Record Key: 67d12573-9e50-4ad1-8f0a-e959aa7aae63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: μTASWako AFP-L3 Calibrator Set
• Version Model Number: 997-60901
• Catalog Number: 997-60901
• 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: true
• 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: 877-714-1924
• Email: diagnostics@wakousa.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085662006168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• JIT: Calibrator, Secondary

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: 2016-11-25

Devices Manufactured by WAKO LIFE SCIENCES, INC.

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• 00085662006168 - μTASWako AFP-L3 Calibrator Set: 2018-07-06In-Vitro Diagnostic Use
• 00085662006168 - μTASWako AFP-L3 Calibrator Set: 2018-07-06 In-Vitro Diagnostic Use