Identity
- Trade Name
- IFA HSV-2 IgG Test Sytem FDA UDI
- Generic Name
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- FA9052G FDA UDI
- Description
- The ZEUS IFA Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- FA9052G FDA UDI
- Primary DI / UDI-DI
- 00845533001564 FDA UDI
- GMDN Term
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/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: Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
IFA HSV-2 IgG Test Sytem by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 e71e8639-9e47-40f3-b065-4b5fe7db8fa6 35 fields · synced May 30, 2026