uTASWako Wash Solution 991-60801

GUDID 04987481164505

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD Immunohistochemistry wash buffer reagent IVD

• Primary Device ID: 04987481164505
• NIH Device Record Key: efb8bc44-c920-417e-aeb8-039a310b5521
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uTASWako Wash Solution
• Version Model Number: 991-60801
• Catalog Number: 991-60801
• Company DUNS: 690598875
• Company Name: FUJIFILM WAKO PURE CHEMICAL CORPORATION
• Device Count: 4
• 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: 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: 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 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987481164505 [Unit of Use]
GS1	10856626006059 [Previous]
GS1	14987481164502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• NSF: Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

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 Wash Solution]

• 10856626006059: In-Vitro Diagnostic Use
• 04987481164505: In-Vitro Diagnostic Use