Radial Immunodiffusion Plates

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

510(k) Number

K830911 ↗

FDA Product Code

DDG

Device Class

Class II

Regulation

21 CFR Part 866.5880

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Bio-Lipid Lipid Control- Level 1, 2 and 3

  Class I

  FDA 510(k) K951749 Active Cleared 15 May 1995

• Biocell Spinal Fluid Control

  Class I

  FDA 510(k) K830179 Active Cleared 18 Feb 1983

• Bio-Csf Liquid Control Level 1 and 2

  Class I

  FDA 510(k) K963551 Active Cleared 7 Oct 1996

• Bio-Lipid Human Serum Hdl and Ldl Calibrators

  Class I

  FDA 510(k) K000056 Active Cleared 24 Feb 2000

• Gemcal Eni Reference Serum

  Class II

  FDA 510(k) K844344 Active Cleared 3 Jan 1985

• What is the Radial Immunodiffusion Plate used for in a clinical setting?

  The Radial Immunodiffusion Plate is designed for quantitative measurement of antigen concentrations in immunology laboratories. It uses a plastic base with agar gel containing specific antiserum to detect and quantify antigens such as transferrin or control substances through immunoprecipitation patterns. This method provides precise, reproducible results for diagnostic purposes.

• Are these plates single-use or reusable?

  These plates are intended for single-use only. They are supplied in sterile packaging by the manufacturer, eliminating the need for additional sterilization procedures. This ensures consistency and reliability in test results while maintaining safety standards.

• What types of antigens can be measured using these plates?

  The plates are specifically designed to measure antigens such as transferrin, along with other antigens and control substances. The agar gel contains antiserum tailored to bind with these specific targets, enabling accurate quantification through immunoprecipitation.

• How should these plates be stored before use?

  The plates should be stored according to the manufacturer’s instructions provided in the packaging. Typically, they are kept in a cool, dry place, protected from direct sunlight and extreme temperatures. Since they are single-use and pre-sterilized, proper storage ensures the integrity of the agar gel and antiserum until use.

• What regulatory pathway does this device follow?

  The Radial Immunodiffusion Plates are regulated under the FDA’s 510(k) clearance process, specifically under product code DDG and categorized under 21 CFR 866.5880. They were granted clearance as substantially equivalent to a predicate device through a traditional review by the Immunology (IM) Advisory Committee, with a decision date of June 10, 1983.