IDS-iSYS Total Testosterone
K-Number: K252728 · 2026-04-15
Device Summary
Frequently Asked Questions
What is the IDS-iSYS Total Testosterone?
IDS-iSYS Total Testosterone is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Immunodiagnostic Systems Limited. The 510(k) number is K252728.
When did IDS-iSYS Total Testosterone receive FDA 510(k) clearance?
IDS-iSYS Total Testosterone received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252728.
Who is the listed applicant for IDS-iSYS Total Testosterone?
The FDA 510(k) record lists Immunodiagnostic Systems Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IDS-iSYS Total Testosterone?
The FDA product code for IDS-iSYS Total Testosterone is CDZ.
Other records listing Immunodiagnostic Systems Limited as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: CDZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.