Identity
- Trade Name
- ELISA EBV-VCA IgG Q Test System FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- Q9Z9201GB FDA UDI
- Description
- The ZEUS ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- Q9Z9201GB FDA UDI
- Primary DI / UDI-DI
- 00845533000475 FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
No
FDA UDI
ELISA EBV-VCA IgG Q Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA).
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI ba2f8005-2b7f-4862-9775-f9fd15678098 35 fields · synced May 30, 2026