CH50 Calibrator 997-43801

GUDID 04987481164512

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent Total complement activity (CH50) IVD, reagent

• Primary Device ID: 04987481164512
• NIH Device Record Key: 30dadb9c-e5f7-46b6-abf9-5d4f1216eff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CH50 Calibrator
• Version Model Number: 997-43801
• Catalog Number: 997-43801
• 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: 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

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

• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower
• Special Storage Condition, Specify: Between 0 and 0 *Store at -10 Degrees Celsius or lower

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856626006151 [Previous]
GS1	04987481164512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954145

FDA Product Code

• DAE: Complement C9, Antigen, Antiserum, Control

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

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