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Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- For the detection and titration of HSV-2 IgG antibodies in human sera FDA UDI
- Model / Reference
- 902600 FDA UDI
- Description
- For the detection and titration of HSV-2 IgG antibodies in human sera FDA UDI
Identifiers
- Primary DI / UDI-DI
- G522902600 FDA UDI
- 510(k) Number
- K791058 FDA UDI
- FDA Product Code
- GQL FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) 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
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- AtheNA Multi-Lyte® HSV-1 & 2 IgG Plus Test System — ZEUS SCIENTIFIC, INC.
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit — HEMAGEN DIAGNOSTICS, INC. · Class II
Cleared under the same submission
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hemagen Diagnostics, Inc.
Sources (1)
- FDA UDI 6b0c3aca-ec78-42a3-bcc0-74ceac533595 36 fields · synced May 30, 2026