Cobas Core FT4 EIA

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Cobas(R) Core FT4 Eia

510(k) Number

K932607 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Cobas Core FT4 EIA used for?

  The Cobas Core FT4 EIA is an enzyme immunoassay designed for the in vitro quantitative measurement of free thyroxine (FT4) in human serum and plasma. FT4 is a key thyroid hormone, and its precise concentration helps clinicians diagnose and monitor thyroid disorders such as hypothyroidism or hyperthyroidism. By providing accurate FT4 readings, this device supports clinical decision-making in thyroid-related patient care.

• How is the Cobas Core FT4 EIA supplied, and is it single-use?

  The Cobas Core FT4 EIA is supplied as a single-use reagent kit. This design ensures consistency and reliability in test results, as each kit is intended for one use only. Single-use kits also reduce the risk of cross-contamination and eliminate the need for cleaning or reprocessing between tests, which is critical for maintaining assay accuracy and patient safety.

• What storage conditions are required for the Cobas Core FT4 EIA?

  The Cobas Core FT4 EIA requires standard laboratory refrigeration between 2°C and 8°C. No additional storage precautions are necessary beyond this temperature range. Proper refrigeration helps preserve the stability and performance of the reagent kit, ensuring reliable assay results when used on the Cobas Core immunoassay analyzer platform.

• Can the Cobas Core FT4 EIA be reused, or is it intended for single-use only?

  The Cobas Core FT4 EIA is explicitly designed for single-use only. Reusing the reagent kit is not recommended, as it could compromise the integrity of the assay, introduce contamination, or lead to inaccurate FT4 measurements. Single-use kits are engineered to deliver consistent and reliable results while minimizing the risk of cross-contamination between samples.

• Is the Cobas Core FT4 EIA compatible with MRI environments?

  No, the Cobas Core FT4 EIA is not intended for use in MRI environments. Since it is not a magnetic resonance-compatible device, it should not be exposed to MRI systems or magnetic fields. This device is strictly for use in clinical chemistry laboratories on the Cobas Core immunoassay analyzer platform, where thyroid hormone analysis is performed.