Identity
- Trade Name
- Varicella-Zoster Virus / VZV IgG IFA 96 Test FDA UDI
- Generic Name
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- For the detection and titration of antibodies to varicella-zoster virus in human sera FDA UDI
- Model / Reference
- 902800 FDA UDI
- Description
- For the detection and titration of antibodies to varicella-zoster virus in human sera FDA UDI
Identifiers
- Primary DI / UDI-DI
- G5229028001 FDA UDI
- 510(k) Number
- K800787 FDA UDI
- FDA Product Code
- GQW FDA UDI
- GMDN Term
- Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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
No
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, fluorescent immunoassay
Varicella-Zoster Virus / VZV IgG IFA 96 Test by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K800787 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
- Hemagen Diagnostics, Inc.
Sources (1)
- FDA UDI 29b9ab21-6c9d-4ae1-8c4e-4eca43b5cc65 36 fields · synced May 30, 2026