Vitamin D Control

GUDID 00850212007089

FUJIREBIO US, INC.

25-Hydroxy vitamin D3 IVD, control

• Primary Device ID: 00850212007089
• NIH Device Record Key: 8e788d60-1747-48cf-91d3-262826bc9c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitamin D Control
• Version Model Number: 2130166
• Company DUNS: 029385775
• Company Name: FUJIREBIO US, 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: 800-531-7963
• Email: customerservice@fdi.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007089 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2019-11-12
• Device Publish Date: 2019-11-04

On-Brand Devices [Vitamin D Control]

• 00850212007034: 2130152
• 00850212007089: 2130166