25-Hydroxy Vitamin D RIA

GUDID 05060169690004

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple form 25-hydroxy Vitamin D IVD, kit, radioimmunoassay

• Primary Device ID: 05060169690004
• NIH Device Record Key: 6fdb33b2-abc9-4735-bbf4-6bb371bac127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 25-Hydroxy Vitamin D RIA
• Version Model Number: AA-35F1
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169690004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991998

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

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