Identity
- Trade Name
- IFA EBV-VCA IgM Test System FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- FA9151M FDA UDI
- Description
- The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- FA9151M FDA UDI
- Primary DI / UDI-DI
- 00845533001588 FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay 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
Category: Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
IFA EBV-VCA IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BioPlex 2200 — Bio-Rad Laboratories · Class II
- AtheNA Multi-Lyte® EBV-VCA IgM Plus Test System — ZEUS SCIENTIFIC, INC.
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 f9e00ebe-ee21-448f-a652-e67f2e44755b 35 fields · synced May 31, 2026