IDS ACTH II

GUDID 05060169696457

IMMUNODIAGNOSTIC SYSTEMS LIMITED

Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 05060169696457
• NIH Device Record Key: ce533844-8e85-4201-bc54-0018b222ef21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDS ACTH II
• Version Model Number: IS-4500NG
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in an upright position

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060169696457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223867

FDA Product Code

• CKG: Radioimmunoassay, Acth

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: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by IMMUNODIAGNOSTIC SYSTEMS LIMITED

• 05060169695986 - IDS Beta CrossLaps® (CTX-I): 2024-01-11
• 05060169696013 - IDS Beta CrossLaps® (CTX-I) Calibrator Set: 2024-01-11
• 05060169696051 - IDS Beta CrossLaps® (CTX-I) Control Set: 2024-01-11
• 05060169696457 - IDS ACTH II: 2023-08-31
• 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