Territin RIA Kit

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K792588 ↗

FDA Product Code

JMG

Device Class

Class II

Regulation

21 CFR Part 866.5340

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Territin RIA Kit used for?

  The Territin RIA Kit is designed for the quantitative measurement of ferritin levels in serum or plasma samples. Ferritin is a key biomarker used to assess iron storage, diagnose iron deficiency, or monitor iron overload disorders such as hemochromatosis. The two-site solid-phase radioimmunoassay technique ensures high sensitivity and specificity for accurate clinical results.

• How is the Territin RIA Kit supplied and what are its handling requirements?

  The Territin RIA Kit is supplied as a sterile, single-use diagnostic reagent system. It is intended exclusively for in vitro diagnostic use in clinical laboratory settings. While no specific MRI safety concerns are noted, standard laboratory precautions should be followed during handling. Storage instructions are not detailed, but refrigeration until use is typical for radioimmunoassay kits to maintain reagent stability.

• Is the Territin RIA Kit reusable or intended for single use?

  The Territin RIA Kit is explicitly designed for single-use only. This ensures consistency in assay performance and minimizes contamination risks, which is critical for accurate ferritin measurement in clinical diagnostics. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway does the Territin RIA Kit follow?

  The Territin RIA Kit is authorized under the FDA’s 510(k) clearance process (K792588) as a Class II device, categorized under product code JMG. This clearance confirms its substantial equivalence to a predicate device and its compliance with FDA requirements for in vitro diagnostic use in immunology applications. The device is not intended for direct patient use but for laboratory analysis.

• Does the kit require special storage conditions beyond standard refrigeration?

  The provided data does not specify unique storage conditions beyond what is typical for radioimmunoassay kits. Refrigeration is generally recommended to preserve reagent integrity until use. Clinicians should follow standard laboratory protocols for handling radioactive materials if applicable, though no additional safety notes are provided in the documentation. Always verify storage guidelines with the manufacturer’s latest instructions.