HDL-C/LDL-C Calibrator 990-28011

GUDID 04987481164550

In-Vitro Diagnostic Use

FUJIFILM WAKO PURE CHEMICAL CORPORATION

High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High-density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator High density lipoprotein (HDL) cholesterol IVD, calibrator

• Primary Device ID: 04987481164550
• NIH Device Record Key: d53325df-9aa3-4dd7-8eab-59f5fc6a54dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDL-C/LDL-C Calibrator
• Version Model Number: 990-28011
• Catalog Number: 990-28011
• 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
• 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
• 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
• 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
• 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	04987481164550 [Unit of Use]
GS1	10856626006035 [Previous]
GS1	14987481164557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001005

FDA Product Code

• JIS: Calibrator, Primary

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 [HDL-C/LDL-C Calibrator]

• 10856626006035: In-Vitro Diagnostic Use
• 04987481164550: In-Vitro Diagnostic Use