Biosign Mono-Infect Mono Hetero Antibody Test

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

Full name

Biosign(Tm) Mono-Infect Mono Hetero Antibody Test

510(k) Number

K925183 ↗

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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See all devices from Princeton Biomedix →

• What is the BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST used for?

  This device is a system test designed to detect mono heterophile antibodies in laboratory settings. It aids in the diagnosis of infectious mononucleosis by identifying antibodies associated with the Epstein-Barr virus infection, supporting clinical evaluation when mono is suspected.

• How is the BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST supplied and is it sterile or single-use?

  The device data does not specify the supply format, sterility, or single-use/reuse status of this test. As a system test for infectious mononucleosis antibody detection, it likely includes reagents and controls for laboratory use, but specific details about packaging, sterility, or disposability are not provided in the authorized information.

• What regulatory pathway was used for the BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST and when was it cleared?

  The device received traditional 510(k) clearance from the FDA on February 23, 1993, under regulation number 866.5640. It was determined to be substantially equivalent to a predicate device, which is the basis for its market authorization in the United States.