Tech Simple Infectious Mononucleosis Serum Control

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

510(k) Number

K922726 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What is the Tech Simple Infectious Mononucleosis Serum Control used for?

  This device is designed to detect heterophile antibodies in serum, plasma, or other body fluids as part of an immunochemical test system. These antibodies are commonly associated with infectious mononucleosis, helping clinicians confirm suspected cases through laboratory testing.

• How is the Tech Simple Infectious Mononucleosis Serum Control supplied?

  The product is supplied as a single-use control, intended exclusively for laboratory settings. It is not reusable and must be used once before disposal, adhering to standard in vitro diagnostic (IVD) protocols.

• Is sterility required for the Tech Simple Infectious Mononucleosis Serum Control?

  The device does not specify sterility requirements in its documentation. It is intended for in vitro diagnostic use only, meaning it is not intended for direct patient administration or procedures requiring sterile conditions.

• What regulatory pathway does this device follow?

  The Tech Simple Infectious Mononucleosis Serum Control is regulated under the FDA’s Traditional 510(k) clearance process, classified as Device Class II. It was cleared under the Immunology advisory committee (IM) with a decision date of October 5, 1992, and falls under regulation number 866.5640.

• How should the Tech Simple Infectious Mononucleosis Serum Control be stored?

  While specific storage instructions are not detailed in the provided data, standard IVD protocols should be followed. This typically includes storing the control in a clean, dry environment away from direct sunlight or extreme temperatures, as per manufacturer guidelines for in vitro diagnostic reagents.