Nichols Advantage Chemiluminescence Free T3 Kit

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

510(k) Number

K965058 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) Assay

  Class II

  FDA 510(k) K042676 Active Cleared 17 Dec 2004

• Nichols Apo B Chemiluminescence Assay

  Class I

  FDA 510(k) K925702 Active Cleared 23 Dec 1992

• Advantage Chemiluminescence Erythropoietin Immunoassay

  Class II

  FDA 510(k) K980737 Active Cleared 23 Mar 1999

• Vitamin D Test System Nichols Advantage 25-Hydroxyvitamin D

  Class II

  FDA 510(k) K012367 Active Cleared 9 Oct 2001

• Nichols Advantage Chemiluminescence Adrenocorticotropic Hormone

  Class II

  FDA 510(k) K962601 Active Cleared 24 Dec 1996

• Aminoglycoside Test System

  Class II

  FDA 510(k) K780048 Active Cleared 20 Jan 1978

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• What is the Nichols Advantage Chemiluminescence Free T3 Kit used for?

  This kit is designed for the quantitative measurement of free triiodothyronine (FT3) in serum or plasma samples. FT3 is a critical marker for assessing thyroid function, and accurate measurement helps clinicians diagnose and monitor conditions like hyperthyroidism or hypothyroidism. The chemiluminescent detection method provides high sensitivity and precision, making it suitable for routine clinical chemistry workflows.

• How is the Nichols Advantage Chemiluminescence Free T3 Kit supplied?

  The kit is supplied as a single-use reagent system, meaning each kit is intended for one-time use only. This design eliminates the need for reprocessing or reuse, reducing the risk of contamination and ensuring consistent, reliable results for each test. The single-use format aligns with standard laboratory practices for in vitro diagnostics.

• Does the kit require special storage conditions?

  No special storage conditions are required beyond standard refrigeration. The kit should be stored refrigerated (typically between 2°C and 8°C) to maintain its stability and performance. This makes it convenient for integration into existing laboratory workflows without additional infrastructure.

• Is the Nichols Advantage Chemiluminescence Free T3 Kit reusable?

  No, the kit is explicitly designed for single-use only. This is a standard practice for in vitro diagnostic reagents to ensure accuracy, safety, and compliance with regulatory standards. Reusing the kit could compromise sterility and result accuracy, which is why it is not intended for repeated use.

• What regulatory pathway does this device follow?

  The Nichols Advantage Chemiluminescence Free T3 Kit holds a Traditional 510(k) clearance (K965058) from the FDA, demonstrating substantial equivalence to a predicate device under regulation number 862.1710. This classification applies to clinical chemistry devices, and the kit is intended for in vitro diagnostic use. The clearance confirms its compliance with safety and performance standards for measuring free T3 in serum or plasma.