Biodex Act-O-Kit Tsh-Ria-

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

510(k) Number

K840088 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Treatment Table, Model #825-100

  Class II

  FDA 510(k) K930262 Active Cleared 29 Mar 1993

• Traction Table Model #825-200

  Class II

  FDA 510(k) K930259 Active Cleared 24 Mar 1993

• Deluxe C Arm Radiological Table, Model #056-004

  Class II

  FDA 510(k) K921501 Active Cleared 15 May 1992

• Urological C-Arm Table, Model #056-450

  Class II

  FDA 510(k) K922591 Active Cleared 27 Nov 1992

• Cardiac Stress Table, 056-180/Univ Roll Stress Att

  Class II

  FDA 510(k) K926082 Active Cleared 30 Dec 1992

• Thyroid Uptake System & Atomlab 950 Med. Spectrome

  Class I

  FDA 510(k) K932153 Active Cleared 7 Sep 1993

See all devices from Biodan Medical Systems, Ltd. →

• What is the BIODEX ACT-O-KIT TSH-RIA used for?

  The BIODEX ACT-O-KIT TSH-RIA is designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in clinical samples. It employs radioimmunoassay techniques to detect and quantify TSH levels, which aids in diagnosing and monitoring thyroid disorders such as hypothyroidism or hyperthyroidism. This precise analytical tool is intended for use in in vitro laboratory settings to support clinical chemistry assessments.

• How is the BIODEX ACT-O-KIT TSH-RIA supplied and what are its sterility requirements?

  The kit is supplied as a single-use diagnostic reagent intended exclusively for in vitro laboratory use. Standard aseptic handling procedures for immunoassay reagents are sufficient—no additional sterility measures are specified beyond typical laboratory practices. This ensures safe and controlled use while maintaining the integrity of the assay components.

• Is the BIODEX ACT-O-KIT TSH-RIA reusable or single-use?

  The BIODEX ACT-O-KIT TSH-RIA is explicitly designed for single-use only. This design choice minimizes cross-contamination risks and ensures consistent, reliable results for each assay. Reuse is not recommended or supported by the manufacturer, as it could compromise the accuracy and validity of the test.

• Are there specific storage conditions for the BIODEX ACT-O-KIT TSH-RIA?

  The kit does not specify unusual storage conditions beyond what is standard for immunoassay reagents in a laboratory setting. It should be stored under typical laboratory conditions—protected from extreme temperatures, light, and moisture—to preserve its performance and accuracy. Always follow manufacturer guidelines for optimal shelf life and usability.

• What regulatory pathway does the BIODEX ACT-O-KIT TSH-RIA follow?

  The BIODEX ACT-O-KIT TSH-RIA is authorized for commercial distribution in the United States under an FDA 510(k) clearance (K840088). It falls under the regulatory classification of Class II medical devices, with a decision of Substantially Equivalent (SESE) to a predicate device. This clearance confirms that the device meets FDA standards for safety and effectiveness as a radioimmunoassay kit for TSH measurement.