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Radial Immuno-Test for Human Factor B

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831959

by Kent Laboratories, Inc.

Identifiers

510(k) Number
K831959 FDA 510(k)
FDA Product Code
JZH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5320 FDA 510(k)
Regulation Number
866.5320 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Radial Immuno-Test for Human Factor B is a radial immunodiffusion kit used for detecting and quantifying Human Factor B in samples. It works by diffusing Human Factor B antigen from a circular well into a gel containing Human Factor B antiserum, forming a precipitin circle that indicates the antigen's concentration.

This device is supplied as a kit and is intended for laboratory use. It is a single-use device and is not MRI safe. The device is authorized under FDA 510(k) clearance with product code JZH and device class 2. It is manufactured by Kent Laboratories, Inc. and has model number K831959.

Frequently asked questions

What is the Radial Immuno-Test for Human Factor B used for?

The Radial Immuno-Test for Human Factor B is a laboratory kit used for detecting and quantifying Human Factor B in samples. It works by diffusing Human Factor B antigen from a circular well into a gel containing Human Factor B antiserum, forming a precipitin circle that indicates the antigen's concentration.

How is the Radial Immuno-Test for Human Factor B supplied?

The device is supplied as a complete kit intended for laboratory use. It is a single-use device and is not MRI safe. The kit includes all necessary components for performing the radial immunodiffusion test to detect and quantify Human Factor B in samples.

What is the regulatory status of the Radial Immuno-Test for Human Factor B?

The device is authorized under FDA 510(k) clearance with product code JZH and device class 2. It was manufactured by Kent Laboratories, Inc. with model number K831959. The clearance was granted through the traditional review process with a decision code of SESE (Substantially Equivalent).

What are the specifications of the Radial Immuno-Test for Human Factor B?

The device is a radial immunodiffusion kit that forms precipitin circles to indicate antigen concentration. It is not MRI safe and is intended for single-use in laboratory settings. The device has product code JZH, device class 2, and was reviewed by the Immunology advisory committee.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959) - Innolitics, Product Info - Radial Immunodiffusion Kits | Kent Laboratories, C-3 Proactivator (Factor B) End Point and/or Overnight Radial ..., RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959) - Innolitics, Kent Laboratories Inc FDA Filings

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kent Laboratories, Inc.

Sources (1)

  • FDA 510(k) K831959 24 fields · synced Sep 24, 2026