Gammadab B-HCG Radioimmunoassay Kit

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K801409 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the Gammadab B-HCG Radioimmunoassay Kit used for?

  The Gammadab B-HCG Radioimmunoassay Kit is designed for the quantitative measurement of beta-human chorionic gonadotropin (β-HCG) in serum or plasma samples. β-HCG is a hormone produced during pregnancy, and its levels are critical for confirming pregnancy, monitoring ectopic pregnancies, and assessing trophoblastic diseases. The kit employs a radioimmunoassay method to detect β-HCG with high sensitivity and specificity, making it suitable for clinical chemistry laboratories.

• Is this kit intended for single-use or reusable applications?

  This kit is explicitly intended for single-use only. Due to its radioactive components, reuse is not recommended or safe. Laboratories must adhere to strict radioisotope safety protocols to ensure proper handling, storage, and disposal of the kit components.

• What safety measures must be followed when using this kit?

  Because the Gammadab B-HCG Radioimmunoassay Kit contains radioactive materials, it requires adherence to comprehensive radioisotope safety protocols. This includes proper storage, handling, and disposal procedures to minimize exposure risks. Laboratories must follow regulatory guidelines for radioactive waste management and ensure all personnel are trained in radiation safety.

• What regulatory classification does this device hold?

  The Gammadab B-HCG Radioimmunoassay Kit is classified as a Class II medical device under FDA regulation 862.1155. It was granted a Traditional 510(k) clearance in 1980, confirming its substantial equivalence to predicate devices. The kit is also listed under product code JHI and falls under the Clinical Chemistry advisory committee (CH).

• How should this kit be stored, and what are the key considerations?

  The kit must be stored in accordance with radiation safety guidelines to prevent contamination or degradation of its components. Storage conditions should maintain the integrity of the radioactive materials and reagents. Laboratories must ensure proper labeling, secure containment, and compliance with local and federal regulations governing radioactive substances. Always refer to the manufacturer’s instructions for specific storage details.