Autokit CH50 995-40801

GUDID 00498748116440

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: 00498748116440
• NIH Device Record Key: 60a53278-db88-417f-8161-35eec48af3fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autokit CH50
• Version Model Number: 995-40801
• Catalog Number: 995-40801
• 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: 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	00498748116440 [Primary]
GS1	00856626006113 [Previous]

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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• 04987481164673 - Autokit Micro Albumin Control Set: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164536 - L-Type LDL-C Reagent 1: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164543 - L-Type LDL-C Reagent 2: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164604 - HR Series NEFA-HR(2) Color Reagent A: 2021-06-09 In-Vitro Diagnostic Use
• 04987481164611 - HR Series NEFA-HR(2) Solvent A: 2021-06-09 In-Vitro Diagnostic Use