Vzvscan(Tm) Latex Aggutination Test

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

510(k) Number

K912239 ↗

FDA Product Code

GQW

Device Class

Class II

Regulation

21 CFR Part 866.3900

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the VZVSCAN Latex Agglutination Test used for?

  The VZVSCAN Latex Agglutination Test is used for the detection of Varicella-Zoster antigen through latex agglutination, as specified in the device name and intended use for laboratory-based microbiology testing.

• How is the VZVSCAN Latex Agglutination Test supplied and what does it include?

  The device is supplied as a test kit and includes a control, as defined in the device name and specifications, intended for use in laboratory settings to detect Varicella-Zoster antigen.

• Is the VZVSCAN Latex Agglutination Test sterile, single-use, or reusable?

  The provided data does not indicate whether the VZVSCAN Latex Agglutination Test is sterile, single-use, or reusable; no such specifications are stated in the device information.