Identity
- Trade Name
- VIDAS® Varicella-Zoster IgG FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum. FDA UDI
- Model / Reference
- 30217 FDA UDI
- Description
- VIDAS VARICEL. ZOSTER IGG assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to Varicella Zoster in human serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026064518 FDA UDI
- 510(k) Number
- K923122 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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)
VIDAS® Varicella-Zoster IgG by Biomerieux , Inc. — 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).
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- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA VZV IgG Test System — ZEUS SCIENTIFIC, INC.
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
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
- Biomerieux , Inc.
Sources (1)
- FDA UDI 01e40ef2-078a-4867-b4bf-e564e0fdb449 35 fields · synced Jun 1, 2026