CH50 Calibrator 997-43801

GUDID 04987481164512

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

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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• 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