Lumipulse G 25-OH Vitamin D Immunoreaction Cartrid

GUDID 04987270235089

FUJIREBIO INC.

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04987270235089
• NIH Device Record Key: ff20f015-0fff-402f-ac2c-ed3ce0c31309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumipulse G 25-OH Vitamin D Immunoreaction Cartrid
• Version Model Number: 235089
• Company DUNS: 710873907
• Company Name: FUJIREBIO INC.
• 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: 610-240-3800
• Email: customersupport@fdi.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Right side up with care; no vibration
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987270235089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153361

FDA Product Code

• MRG: System, Test, Vitamin D

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

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