1,25 Dihydroxy Vitamin D RIA

GUDID 05060169690011

IMMUNODIAGNOSTIC SYSTEMS LIMITED

1,25-Dihydroxy vitamin D3 IVD, kit, liquid chromatography

• Primary Device ID: 05060169690011
• NIH Device Record Key: 3cbd3d28-f155-4dc9-b9de-bd2c09915d58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1,25 Dihydroxy Vitamin D RIA
• Version Model Number: AA-54F1
• Company DUNS: 494268600
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• 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: 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: +4401915190660
• Email: info.uk@idsplc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store radioactive materials in the original container in a specifically designated properly labelled area
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169690011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042519

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: 2016-04-01

On-Brand Devices [1,25 Dihydroxy Vitamin D RIA]

• 05060169690028: AA-54F2
• 05060169690011: AA-54F1