Digoxin Radioimmunoassay Kit

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Digoxin Kit

510(k) Number

K823014 ↗

FDA Product Code

DPB

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

• Human Follicle Stimulating Hormone

  Class I

  FDA 510(k) K780016 Active Cleared 3 Feb 1978

• Luteinizing Hormone

  Class I

  FDA 510(k) K810741 Active Cleared 31 Mar 1981

• B-GCG System by RIA

  Class II

  FDA 510(k) K830526 Active Cleared 5 Apr 1983

• Thyroid Stimulating Hormone

  Class II

  FDA 510(k) K822935 Active Cleared 1 Nov 1982

• Follicle Stimulating Hormone (Fsh)

  Class II

  FDA 510(k) K810867 Active Cleared 14 Apr 1981

• Rabbit Antibody to Digoxin

  Class II

  FDA 510(k) K780316 Active Cleared 17 Mar 1978

See all devices from Pcl-Ria, Inc. →

• What is the Digoxin Radioimmunoassay Kit used for?

  The Digoxin Radioimmunoassay Kit (125-I) is designed for quantifying digoxin levels in clinical samples as part of toxicology assessments. Digoxin is a cardiac glycoside, and accurate measurement helps clinicians monitor therapeutic levels or identify potential toxicity in patients. This kit employs a rabbit antibody and charcoal separation to ensure precise detection, making it suitable for laboratories specializing in clinical toxicology.

• How is the Digoxin Radioimmunoassay Kit supplied, and is it single-use?

  The kit is supplied as a single-use diagnostic reagent system intended exclusively for in vitro use in clinical laboratories. This design ensures consistency and reliability in results, as reuse could compromise accuracy or introduce contamination. Laboratories must adhere to standard radioimmunoassay protocols when using the kit.

• Does this kit require special handling due to radioactive materials?

  Yes, the Digoxin Radioimmunoassay Kit contains 125-Iodine, a radioactive isotope, which necessitates compliance with strict laboratory protocols for handling radioactive materials. Only facilities equipped to manage such substances safely should use this kit. Proper training, shielding, and disposal procedures are essential to mitigate risks.

• Are there any specific storage or shelf-life details provided for this kit?

  The provided documentation does not specify storage conditions or shelf life for the Digoxin Radioimmunoassay Kit. Laboratories should follow general best practices for radioactive reagents, including storage in a secure, temperature-controlled environment and adherence to manufacturer guidelines (if available) to maintain integrity until use.

• Is reprocessing or sterilization of this kit allowed or recommended?

  The kit is intended for single-use only, and there are no instructions provided regarding reprocessing or sterilization. Reusing or reprocessing this diagnostic reagent could compromise its performance, accuracy, or safety. Laboratories must treat it as a disposable item to ensure reliable results and compliance with regulatory standards.