Wellcozyme HSV WZO2

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

510(k) Number

K875311 ↗

FDA Product Code

GQN

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Wellcome Diagnostics →

• What is the Wellcozyme HSV WZO2 used for?

  The Wellcozyme HSV WZO2 is an antigen test designed to aid in the diagnosis of Herpesvirus Hominis 1 and 2. It is intended for microbiology laboratory use as a component for use with Wellcozyme instrumentation.

• How is the Wellcozyme HSV WZO2 supplied?

  The Wellcozyme HSV WZO2 is supplied as a component for use with Wellcozyme instrumentation. It is a Class II device cleared by the FDA under product code GQN and is intended for microbiology laboratory use.

• What is the regulatory status of the Wellcozyme HSV WZO2?

  The Wellcozyme HSV WZO2 is a Class II device cleared by the FDA under product code GQN. It was cleared through the traditional 510(k) process with K number K875311 and is substantially equivalent to other predicate devices.

• Is the Wellcozyme HSV WZO2 a single-use device?

  The device information does not specify whether the Wellcozyme HSV WZO2 is single-use or reusable. As a diagnostic reagent component for laboratory use, its intended usage would depend on the specific laboratory protocols and manufacturer's instructions.