Identity
- Trade Name
- IFA HSV-1 IgG Test System FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Herpes Simplex Virus-1 (HSV-1) 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
- FA9051G FDA UDI
- Description
- The ZEUS IFA Herpes Simplex Virus-1 (HSV-1) 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
- FA9051G FDA UDI
- Primary DI / UDI-DI
- 00845533001557 FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) 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 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
IFA HSV-1 IgG Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
- HSV 1 IgG 120 Test Kit — Scimedx Corp. · Class II
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- Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test — HEMAGEN DIAGNOSTICS, INC. · Class II
- HSV 1 10 Well; 10 pk — Scimedx Corp. · Class II
- HSV-1 IgG Test System, 120 Tests — BION ENTERPRISES, LTD. · Class II
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 fac53d1a-09fc-45c1-b9a8-d34471a204e4 35 fields · synced Jun 6, 2026