IDS-iSYS 25 VitDS

GUDID 05060169690622

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple form 25-hydroxy Vitamin D IVD, reagent

• Primary Device ID: 05060169690622
• NIH Device Record Key: ca8bef00-d04c-4704-9ebf-9c8fcbff5158
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS 25 VitDS
• Version Model Number: IS-2500
• 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: 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: +4401915190660
• Email: techsupport.uk@idsplc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridge and calibrators in an upright position in the dark at 2 - 8 °C. Do not freeze the cartridge or the calibrators.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169690622 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-22

On-Brand Devices [IDS-iSYS 25 VitDS]

• 05060169690622: IS-2500
• 05060169695283: IS-2500N