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Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- For the detection and titration of HSV-1 IgG antibodies in human sera FDA UDI
- Model / Reference
- 902501 FDA UDI
- Description
- For the detection and titration of HSV-1 IgG antibodies in human sera FDA UDI
Identifiers
- Primary DI / UDI-DI
- G5229025011 FDA UDI
- 510(k) Number
- K791058 FDA UDI
- FDA Product Code
- GQL FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 FDA UDI
- 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
No
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
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit by Hemagen Diagnostics, Inc. — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
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
- IFA HSV-1 IgG Test System — ZEUS SCIENTIFIC, INC.
- HSV 1 10 Well; 10 pk — Scimedx Corp. · Class II
- HSV-1 IgG Test System, 120 Tests — BION ENTERPRISES, LTD. · Class II
- Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test — HEMAGEN DIAGNOSTICS, INC. · Class II
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hemagen Diagnostics, Inc.
Sources (2)
- FDA UDI ddefb2a1-98c4-4c1a-8416-053d7ea85c28 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026