IDS-iSYS 25 VitDS Control Set

GUDID 05060169695306

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multiple form 25-hydroxy Vitamin D IVD, control

• Primary Device ID: 05060169695306
• NIH Device Record Key: 4c544b41-8e5c-4e50-98cc-fc799eb952d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS 25 VitDS Control Set
• Version Model Number: IS-2530
• 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: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.uk@idsplc.com
• Phone: +4401915190660
• Email: techsupport.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 the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the controls in an upright position in the dark at 2 - 8 °C.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169695306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161831

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: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [IDS-iSYS 25 VitDS Control Set]

• 05060169690752: IS-2530
• 05060169695306: IS-2530