uTASWako AFP-L3 Control H 993-61101

GUDID 04987481164451

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

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

• Primary Device ID: 04987481164451
• NIH Device Record Key: 9ee2347f-e83b-483b-a435-199eaafd5690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uTASWako AFP-L3 Control H
• Version Model Number: 993-61101
• Catalog Number: 993-61101
• 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 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
• 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	04987481164451 [Unit of Use]
GS1	10856626006073 [Previous]
GS1	14987481164458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100464

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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 AFP-L3 Control H]

• 10856626006073: In-Vitro Diagnostic Use
• 04987481164451: In-Vitro Diagnostic Use