Identity
- Trade Name
- HSV-1 IgG Antigen Wells FDA UDI
- Generic Name
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
- Model / Reference
- EL0901 FDA UDI
Identifiers
- Catalog Number
- EL0901 FDA UDI
- Primary DI / UDI-DI
- 10816101022363 FDA UDI
- FDA Product Code
- MXJ FDA UDI
- GMDN Term
- Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, reagent 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, reagent
HSV-1 IgG Antigen Wells by DiaSorin Molecular LLC — Class II — 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, reagent.
- HSV-1 ELISA IgG Conjugate — DiaSorin Molecular LLC · 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- DiaSorin Molecular LLC
Sources (1)
- FDA UDI be13eaf3-aee8-407f-83b1-08a6ce3ccb04 35 fields · synced Jun 9, 2026