Immuchem TSH-MW ELISA

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K920442 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Immuchem Neonatal TSH-MP ELISA

  Class II

  FDA 510(k) K913963 Active Cleared 13 Dec 1991

• Immuchem Prl-Mw Elisa

  Class I

  FDA 510(k) K922715 Active Cleared 5 Oct 1992

• Lympho Sep(Tm)

  Class I

  FDA 510(k) K902445 Active Cleared 22 Aug 1990

• Immuchem Lh-Mw Elisa

  Class I

  FDA 510(k) K922944 Active Cleared 2 Feb 1993

• Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa Kit

  Class I

  FDA 510(k) K922376 Active Cleared 5 Oct 1992

• 17-Alpha-Hydroxyprogesterone (17-Oh-P) Neo. Ria

  Class I

  FDA 510(k) K885198 Active Cleared 23 Feb 1989

See all devices from Icn Biomedicals, Inc. →

• What is the Immuchem TSH-MW ELISA used for?

  The Immuchem TSH-MW ELISA is designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma samples. It employs a sandwich immunoassay method with monoclonal antibodies to ensure accurate detection of TSH levels, making it a reliable diagnostic tool in clinical chemistry for assessing thyroid function.

• How is the Immuchem TSH-MW ELISA supplied?

  This device is supplied as a single-use in vitro diagnostic kit, containing all necessary reagents for laboratory testing. Each kit is intended for one-time use only, ensuring sterility and consistency in results.

• Is the Immuchem TSH-MW ELISA sterile and reusable?

  The kit is supplied sterile and is intended for single-use only. Reuse is not recommended or supported, as it could compromise sterility and accuracy of the assay results.

• What regulatory clearance does the Immuchem TSH-MW ELISA hold?

  The Immuchem TSH-MW ELISA holds an FDA 510(k) clearance (K920442) and is classified as a Class II device. This clearance confirms compliance with established standards for diagnostic accuracy and reliability, ensuring its suitability for clinical use.

• What storage requirements apply to the Immuchem TSH-MW ELISA?

  While specific storage instructions are not detailed in the provided data, single-use ELISA kits like this typically require refrigeration (between 2°C and 8°C) to maintain reagent stability. Always refer to the included package insert for precise storage guidelines to preserve assay performance.