Viro Research, Inc.
FDA registration: United States Last updated 23 May 2026
- Devices
- 7
- Registries
- GUDIDFDA 510(k)
- FDA recalls
- 0
Catalogue
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
ZosterGent VZV Identification Reagent ZG-VL-US Ref ZG-VL-US
What Viro Research, Inc. makes
Viro Research, Inc. manufactures in vitro diagnostic reagents designed to identify the varicella-zoster virus (VZV) antigen. These products are intended for laboratory use in detecting VZV in clinical samples, aiding in the diagnosis of infections such as shingles and chickenpox.
The company’s VZV antigen reagents are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. The products are based in the United States.
Frequently asked questions
What types of medical devices does Viro Research, Inc. manufacture?
Viro Research, Inc. specializes in in vitro diagnostic (IVD) reagents. Specifically, their primary product category is the varicella-zoster virus (VZV) antigen IVD reagent, designed for laboratory use to detect VZV in clinical samples. These reagents help diagnose infections like shingles and chickenpox by identifying the virus’s antigen.
Where is Viro Research, Inc. based, and how does that affect its regulatory standing?
Viro Research, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. Their VZV antigen reagents fall under Class II classification, meaning they undergo a premarket notification (510(k)) process and are listed in the FDA’s Unique Device Identifier (UDI) system to ensure compliance with U.S. regulatory requirements.
Which regulatory registries or databases list Viro Research, Inc.’s devices?
Viro Research, Inc.’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that the company’s VZV antigen reagents have undergone the necessary regulatory processes to demonstrate safety and effectiveness for their intended use in diagnosing VZV-related infections.
How are Viro Research, Inc.’s devices classified under FDA regulations?
The company’s VZV antigen IVD reagents are classified as Class II medical devices by the FDA. This classification requires manufacturers to submit a 510(k) premarket notification to demonstrate that their device is substantially equivalent to a legally marketed predicate device. Class II devices involve moderate risk and require special controls beyond general controls to ensure safety and performance.
Information
- FDA registration
- United States