Total T3 Enzyme Immunoassay Test Kit, Model BC-1005

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

510(k) Number

K991311 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Total T3 Enzyme Immunoassay Test Kit BC-1005 used for?

  The Total T3 Enzyme Immunoassay Test Kit, Model BC-1005, is an in vitro diagnostic device intended specifically for measuring total triiodothyronine (T3) levels in human serum or plasma. T3 is a thyroid hormone critical for metabolism, and accurate measurement helps clinicians assess thyroid function, diagnose disorders like hyperthyroidism or hypothyroidism, and monitor treatment efficacy.

• How is the Total T3 Enzyme Immunoassay Test Kit BC-1005 supplied, and is it single-use?

  The kit is supplied as a single-use device, meaning each kit is designed for one test procedure only. This ensures sterility and consistency in results, as reuse could compromise accuracy or introduce contamination. The manufacturer provides the kit pre-packaged for immediate use without requiring additional preparation steps.

• Is the Total T3 Enzyme Immunoassay Test Kit BC-1005 sterile?

  The kit is intended for in vitro diagnostic use, and while the device data does not explicitly state sterility beyond its single-use classification, single-use diagnostic kits like this are typically manufactured and packaged under controlled conditions to maintain sterility until first use. Always follow the manufacturer’s instructions for handling and storage to preserve integrity.

• What regulatory approval does the Total T3 Enzyme Immunoassay Test Kit BC-1005 hold?

  The Total T3 Enzyme Immunoassay Test Kit, Model BC-1005, is cleared by the FDA under 510(k) notification (K991311) and classified as a Class II device with special controls. This clearance indicates the device is deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in measuring total triiodothyronine levels.