Identity
- Trade Name
- Varicella Zoster Virus (VZV) IgG ELISA FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. FDA UDI
- Model / Reference
- EIA-2808 FDA UDI
- Description
- The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. FDA UDI
Identifiers
- Catalog Number
- EIA-2808 FDA UDI
- Primary DI / UDI-DI
- 00840239028082 FDA UDI
- 510(k) Number
- K961012 FDA UDI
- FDA Product Code
- LFY FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index 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
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
Yes
FDA UDI
Varicella Zoster Virus (VZV) IgG ELISA by DRG International, 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 avidity index IVD, kit, enzyme immunoassay (EIA).
Cleared under the same submission
K961012 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
- DRG International, Inc.
Sources (1)
- FDA UDI f1c39e6e-a64d-4c47-bc56-af50952052ae 37 fields · synced Jun 1, 2026