IDS-i10

GUDID 05060169693968

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Multichannel immunoassay analyser IVD

• Primary Device ID: 05060169693968
• NIH Device Record Key: 8a56e9af-dd99-4182-8fb2-bf6f598b3de3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS-i10
• Version Model Number: IS-810400
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: false
• 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
• 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
• 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 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage 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
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169693968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091849

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: 2023-07-05
• Device Publish Date: 2023-06-27

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• 05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set: 2024-01-11
• 05060169696457 - IDS ACTH II: 2023-08-31
• 05060169696495 - IDS ACTH II Calibrator Set: 2023-08-31
• 05060169696532 - IDS ACTH II Control Set: 2023-08-31
• 05060169691148 - IDS-iSYS SDSpeed Calc: 2023-07-05
• 05060169691261 - IDS Androstenedione: 2023-07-05