Magic Monoclonal Antibody TSH Radioimmunoassay

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

Full name

Magic Monoclonal Antibody Tsh(Mab Tsh)Radioimmunoa

510(k) Number

K851329 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Magic Monoclonal Antibody TSH Radioimmunoassay Kit used for?

  This kit is designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma samples. It employs monoclonal antibodies and competitive binding principles to accurately determine TSH levels, aiding in the diagnostic evaluation of thyroid function. This is particularly useful for identifying conditions like hypothyroidism or hyperthyroidism by providing precise hormone concentration readings.

• How is the Magic Monoclonal Antibody TSH Radioimmunoassay Kit supplied, and is it single-use?

  The kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time use in clinical chemistry laboratories. This ensures consistency and reliability in test results while minimizing the risk of cross-contamination or carryover between samples. Single-use also aligns with standard laboratory practices for maintaining sterility and accuracy in diagnostic testing.

• What storage conditions are required for the Magic Monoclonal Antibody TSH Radioimmunoassay Kit?

  The kit does not require any special storage conditions beyond standard refrigeration. This makes it convenient for laboratories to store and use without needing additional infrastructure, such as freezers or controlled-temperature environments. Always follow the manufacturer’s instructions to ensure the kit remains effective until use.

• Is this device reusable, or is it intended for one-time use?

  The Magic Monoclonal Antibody TSH Radioimmunoassay Kit is explicitly designed for single-use only. Reusing components could compromise the accuracy of results, introduce contamination, or violate sterility protocols. Single-use kits are standard in clinical diagnostics to ensure patient safety and reliable outcomes.

• What regulatory pathway was followed for this device?

  This device was cleared under the FDA’s 510(k) pathway, specifically clearance number K851329. It was determined to be substantially equivalent to predicate devices under Regulation 862.1690 for radioimmunoassay applications. This pathway ensures that the device meets established safety and performance standards for in vitro diagnostic use.