IDS-iSYS Trigger Set

GUDID 05425030421024

Immunodiagnostic Systems SA

Multiple clinical chemistry analyser IVD, laboratory, automated Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory Multiple clinical chemistry analyser IVD, laboratory

• Primary Device ID: 05425030421024
• NIH Device Record Key: 06221913-4693-4edd-b29b-11adfba553f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-iSYS Trigger Set
• Version Model Number: IS-CT100
• 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 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position in the dark at 15 to 25 degrees celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05425030421024 [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
• 05425030421024 - IDS-iSYS Trigger Set: 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