MRI HCG-Beta RIA Kit Cat. #MR-10100

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

510(k) Number

K801491 ↗

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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• What clinical setting is this device intended for, and how is it typically used?

  This MRI HCG-Beta RIA Kit (Cat. #MR-10100) is designed for use in clinical chemistry laboratories. It is an in vitro diagnostic radioimmunoassay (RIA) device intended for the quantitative measurement of human chorionic gonadotropin-beta (HCG-beta) in serum or plasma samples. It aids in detecting pregnancy or monitoring gynecological conditions by visually interpreting HCG levels, following standard laboratory protocols for RIA procedures.

• Is this device single-use or reusable, and what does that mean for its handling?

  The MRI HCG-Beta RIA Kit is supplied as a single-use, non-sterile reagent system. This means each kit is intended for one-time use only and should not be reused. Proper handling and disposal per laboratory protocols are required to ensure accuracy and prevent contamination.

• What storage requirements should I follow for this kit?

  The MRI HCG-Beta RIA Kit requires proper storage as detailed in the accompanying instructions. While the data does not specify exact storage conditions (e.g., temperature or humidity), it is critical to follow the manufacturer’s guidelines to maintain the integrity of the reagents. Always store the kit in a way that prevents exposure to extreme temperatures, light, or contamination.

• How is this device regulated, and what does that mean for its use in clinical practice?

  This device is regulated under the FDA’s 510(k) clearance pathway, with the clearance number K801491. It is classified as a Class II medical device under product code JHI and regulatory classification 862.1155. This means it has undergone a review by the FDA to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in clinical chemistry settings. Its regulatory status confirms it is intended for prescription use and visual interpretation of HCG-beta levels.