TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093

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

510(k) Number

K921700 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K924259 Active Cleared 25 Nov 1992

• Tsh Enzyme Immunoassay Test Kit No. Mb-1093

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  FDA 510(k) K874061 Active Cleared 3 Nov 1987

• Hcg Enzyme Immunoassay Test Kit Catalog #mb-1013

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• Medix Biotech Hghenzyme Immunoassay Test Kit

  Class I

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• Medix Biotech Prolactin Enzyme Immuno. Test Kit

  Class I

  FDA 510(k) K873355 Active Cleared 9 Oct 1987

• Medix Visual Urine Hcg (7/7) Test

  Class II

  FDA 510(k) K850949 Active Cleared 12 Apr 1985

See all devices from Medix Biotech, Inc. →

• What is the TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093 used for?

  The TSH Enzyme Immunoassay Test Kit (Cat. No. KIF4093) is designed to quantitatively measure thyroid-stimulating hormone (TSH) levels in serum or plasma samples. TSH is a critical marker for diagnosing and monitoring thyroid disorders, such as hypothyroidism (underactive thyroid) and hyperthyroidism (overactive thyroid). By providing precise TSH concentrations, this kit aids clinicians in assessing thyroid function and guiding treatment decisions.

• How is the TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093 supplied, and what does a kit include?

  The kit is supplied as a complete in vitro diagnostic device, containing all necessary reagents and components required to perform the enzyme-linked immunoassay for TSH. This includes standardized reagents, assay buffers, and consumables aligned with standard clinical chemistry laboratory protocols. No additional items are required beyond those provided in the kit, ensuring ease of use in a clinical setting.

• Is the TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093 sterile, and how should it be stored?

  The kit is intended for single-use in clinical chemistry laboratories, and while the specific sterility claims are not detailed beyond standard industry practices for immunoassay kits, it adheres to typical sterile or aseptic handling protocols for diagnostic reagents. Storage instructions are outlined in the accompanying documentation, but generally, no special storage conditions are required beyond maintaining the kit in a clean, dry environment, protected from extreme temperatures or direct light, as per the manufacturer’s guidelines.

• Can the TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093 be reused, or is it designed for single-use?

  The kit is explicitly designed for single-use only. Enzyme immunoassay reagents and components are formulated for one-time testing to ensure accuracy, reliability, and patient safety. Reusing the kit could compromise test validity due to potential contamination or degradation of reagents, which may lead to inaccurate TSH measurements.

• What regulatory pathway does the TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093 follow, and what does this mean for users?

  The kit has received FDA 510(k) clearance under the classification 'Radioimmunoassay, Thyroid-Stimulating Hormone' (Regulation 862.1690), confirming it meets U.S. regulatory standards for safety and effectiveness as a Class II medical device. This clearance ensures the kit adheres to stringent quality and performance criteria, providing users—such as clinical laboratories—with confidence in its diagnostic reliability for TSH measurement.