uTASWako i30 991-60301

GUDID 04987481164680

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Electrophoresis analyser IVD, automated

• Primary Device ID: 04987481164680
• NIH Device Record Key: 747bb4d8-075b-4dae-bb3c-6fe3fd51a5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uTASWako i30
• Version Model Number: 991-60301
• Catalog Number: 991-60301
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL 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: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com
• Phone: 781-323-5300
• Email: fmsuregulatoryaffairs@fujifilm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856626006229 [Previous]
GS1	04987481164680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• OUE: Micro Total Analysis Instrument System

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: 2020-11-02
• Device Publish Date: 2020-10-23

On-Brand Devices [uTASWako i30]

• 00856626006229: In-Vitro Diagnostic Use
• 04987481164680: In-Vitro Diagnostic Use