Identity
- Trade Name
- ELISA EBNA-1 IgG Test Sytem FDA UDI
- Generic Name
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 9Z9461G FDA UDI
- Description
- The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 9Z9461G FDA UDI
- Primary DI / UDI-DI
- 00845533000437 FDA UDI
- GMDN Term
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody 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 EBNA-1 IgG Test Sytem by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody 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 |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 017ebd68-ed67-47b2-bcf7-ae7d5514c6a7 35 fields · synced May 30, 2026