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ZosterGent VZV Identification Reagent ZG-VL-US

by Viro Research, Inc. FDA registration: United States GUDID

Product code GQW

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860002913544 UDI-DIDate30 Oct 2020ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
ZosterGent VZV Identification Reagent
Generic Name
Varicella-zoster virus (VZV) antigen IVD, reagent
Model / Ref / Catalog
ZG-VL-US, ZG-VL4-US
Primary DI / UDI-DI
00860002913544
510(k) Number
FDA Product Code
GQW
GMDN Term
Varicella-zoster virus (VZV) antigen IVD, reagent
Device Class
Class II
Regulation Number
866.3900
Commercial Distribution
In Commercial Distribution
Size
Total Volume — 3 Milliliter

Related devices

Category: Varicella-zoster virus (VZV) antigen IVD, reagent

Cleared under the same submission (K942743)

Other devices from Viro Research, Inc.

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI a69966a0-3de6-47bf-9b29-8e76b33a7ad2 37 fields · synced 22 Oct 2026