ELIAS TMAB

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K925923 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K944334 Active Cleared 17 Apr 1995

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  FDA 510(k) K924421 Active Cleared 30 Nov 1992

• Syn Elisa Micro Albumin

  Class I

  FDA 510(k) K920216 Active Cleared 11 Mar 1992

See all devices from Elias U.S.A., Inc. →

• What is the ELIAS TMAB device used for?

  The ELIAS TMAB is a laboratory device designed to detect thyroid autoantibodies in patient samples for diagnostic purposes. It helps in identifying autoimmune thyroid conditions by measuring specific antibodies in the blood.

• Is the ELIAS TMAB a single-use device or can it be reused?

  The device is not specified as single-use or reusable in the available information. It is classified as a Class II device with special controls, and appropriate handling protocols should be followed based on the manufacturer's instructions.

• What are the storage requirements for the ELIAS TMAB system?

  The ELIAS TMAB requires appropriate storage conditions as specified by the manufacturer. While specific temperature ranges aren't provided in the data, laboratory devices typically need to be stored in a controlled environment to maintain their integrity and functionality.

• What regulatory approvals does the ELIAS TMAB have?

  The ELIAS TMAB received FDA 510(k) clearance on January 14, 1993, as a Class II device with special controls. It is manufactured by Elias U.S.A., Inc. and is intended for laboratory use only.