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Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection. FDA UDI
- Model / Reference
- 720-380 FDA UDI
- Description
- ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection. FDA UDI
Identifiers
- Catalog Number
- 720-380 FDA UDI
- Primary DI / UDI-DI
- B3507203800 FDA UDI
- 510(k) Number
- K981867 FDA UDI
- FDA Product Code
- LFY FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- ELISA VZV IgG Bulk Test System — ZEUS SCIENTIFIC, INC.
- ASI VZV IgG EIA Test — Arlington Scientific, Inc. · Class II
- AccuDiag ™ — Diagnostic Automation, Inc. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- VIDAS® Varicella-Zoster IgG — BIOMERIEUX , INC. · Class II
- ELISA VZV IgG Test System — ZEUS SCIENTIFIC, INC.
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
Cleared under the same submission
K981867 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA UDI 62aff8d5-4917-49eb-a940-cfc6741e9abd 36 fields · synced Jun 8, 2026