Fluorescent Treponemel Antibody-Absorb

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843613 ↗

FDA Product Code

GMS

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Fluorescent Treponemel Antibody-Absorb test used for?

  The Fluorescent Treponemel Antibody-Absorb test is used in microbiology for the detection of antibodies, specifically designed to identify specific immune responses as a fluorescent treponemal antibody absorption (FTA-ABS) test.

• How is the Fluorescent Treponemel Antibody-Absorb test supplied and cleared?

  The device is supplied as a traditional 510(k) cleared product with product code GMS and regulation number 866.3830, indicating it was found substantially equivalent to a predicate device through the FDA's traditional 510(k) pathway.

• What type of laboratory setting is the Fluorescent Treponemel Antibody-Absorb test intended for?

  The test is intended for use in laboratory settings, specifically within microbiology, as indicated by its classification and intended use for detecting antibodies in such environments.