IDS i20

GUDID 05060169696693

Automated analyser for in-vitro diagnosis of clinical biology

IMMUNODIAGNOSTIC SYSTEMS FRANCE

Multichannel immunoassay analyser IVD

• Primary Device ID: 05060169696693
• NIH Device Record Key: bf79d074-bea7-4e91-85c9-d3532356adb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS i20
• Version Model Number: IS-910400
• Company DUNS: 381472984
• Company Name: IMMUNODIAGNOSTIC SYSTEMS FRANCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169696693 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-30
• Device Publish Date: 2024-12-20

Devices Manufactured by IMMUNODIAGNOSTIC SYSTEMS FRANCE

• 05060169696693 - IDS i20: 2024-12-30Automated analyser for in-vitro diagnosis of clinical biology
• 05060169696693 - IDS i20: 2024-12-30 Automated analyser for in-vitro diagnosis of clinical biology
• 03760173851010 - IDS-iSYS Cuvettes: 2019-12-23