Identity
- Trade Name
- HSV 2 IgG 120 Test Kit FDA UDI
- Generic Name
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- I-HV201G FDA UDI
Identifiers
- Catalog Number
- I-HV201G FDA UDI
- Primary DI / UDI-DI
- 00813545025717 FDA UDI
- 510(k) Number
- K905608 FDA UDI
- FDA Product Code
- GQL FDA UDI
- GMDN Term
- Herpes simplex virus 2 (HSV2) 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 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
HSV 2 IgG 120 Test Kit by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay.
- HSV-2 IgG Test System, 120 Tests — BION ENTERPRISES, LTD. · Class II
- HSV 2 10 Well; 10 pk — Scimedx Corp. · Class II
Cleared under the same submission
K905608 also covers:
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
- Scimedx Corp.
Sources (1)
- FDA UDI b3c420fb-f5e3-4a96-b154-fca313f7ca56 35 fields · synced Jun 8, 2026