Fiax Transferrin Test Kit

No FDA recalls on record, checked 5 Oct 2026.

510(k) Number

K842071 ↗

FDA Product Code

DDI

Device Class

Class II

Regulation

21 CFR Part 866.5880

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Fiax Transferrin Test Kit used for?

  The Fiax Transferrin Test Kit is designed to measure transferrin levels in serum, plasma, and other body fluids using fluorescent immunochemical techniques. Transferrin is a key serum protein responsible for iron transport, so this assay helps clinicians evaluate conditions related to iron metabolism disorders or protein deficiencies, such as iron-deficiency anemia or hypoproteinemia.

• How is the Fiax Transferrin Test Kit supplied, and is it single-use?

  The kit is supplied as a diagnostic reagent kit intended for in vitro use in clinical laboratories. It contains all necessary components, including FITC-labeled antigen, antiserum, and control materials. Due to its composition and regulatory classification, the kit is intended for single-use only to ensure accuracy and prevent cross-contamination.

• Does the kit require special storage conditions?

  Yes, the kit must be stored under controlled conditions to preserve reagent integrity. While specific storage temperatures or humidity requirements aren’t detailed in the data, typical immunoassay kits like this generally require refrigeration (2–8°C) and protection from light. Always refer to the included instructions for precise storage guidelines to maintain test validity.

• Is sterility or MRI safety relevant for this device?

  The provided data does not specify any sterility requirements or MRI safety considerations for the Fiax Transferrin Test Kit. It is classified as a Class II diagnostic device under FDA 510(k) clearance (K842071) and is intended for laboratory use, where standard aseptic practices apply. No additional precautions beyond typical immunoassay handling are mentioned.

• What regulatory pathway does this kit follow?

  The Fiax Transferrin Test Kit follows the FDA 510(k) clearance pathway, specifically under the Immunology specialty category (reviewed by the Immunology/Microbiology Advisory Committee). It was granted Substantially Equivalent (SESE) status in 1984 (clearance K842071) and adheres to Class II medical device standards. This classification ensures it meets stringent performance and safety criteria for in vitro diagnostic use.