IDS-iSYS Cartridge Check System (CCS)

GUDID 05425030426012

Immunodiagnostic Systems SA

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• Primary Device ID: 05425030426012
• NIH Device Record Key: 876d2fe1-f28b-48f9-b88b-708dc9640b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS Cartridge Check System (CCS)
• Version Model Number: IS-6010
• Company DUNS: 372668418
• Company Name: Immunodiagnostic Systems SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com
• Phone: +32042522636
• Email: info.be@idsplc.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the cartridges in a vertical position. Do not freeze the cartridges
• 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	05425030426012 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2019-12-23
• Device Publish Date: 2016-04-01

Devices Manufactured by Immunodiagnostic Systems SA

• 05425030421024 - IDS-iSYS Trigger Set: 2019-12-23
• 05425030426012 - IDS-iSYS Cartridge Check System (CCS): 2019-12-23
• 05425030426012 - IDS-iSYS Cartridge Check System (CCS): 2019-12-23
• 05425030421017 - IDS-iSYS System Liquid (Syst. l): 2018-03-29
• 05425030421031 - IDS-iSYS Wash Solution (Wash S): 2018-03-29