IDS-iSYS Total Testosterone Control Set

Basic Information

• Brand Name: IDS-iSYS Total Testosterone Control Set
• Primary DI: 05060169690875
• Version / Model: N/A
• Catalog Number: IS-5030
• Company Name: IMMUNODIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 494268600
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-17
• Public Version: 1
• Public Version Date: 2026-04-27
• Public Version Status: New
• Public Device Record Key: 78bebd16-6fd9-4bc1-ae9a-16121917b890

Device Description

The IDS-iSYS Total Testosterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS Total Testosterone on the IDS System.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58380	Total testosterone IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total testosterone in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060169690875	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store the controls in an upright position prior to use