Identity
- Trade Name
- SAS Herpes Check Test FDA UDI
- Generic Name
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 & 2 antigens in the eye and genital vesicular fluid. FDA UDI
- Model / Reference
- 062002-W FDA UDI
- Description
- SAS Herpes Check lateral flow test kit is a visual and rapid assay for the qualitative detection of Herpes Simplex Virus Types 1 & 2 antigens in the eye and genital vesicular fluid. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000134 FDA UDI
- GMDN Term
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
SAS Herpes Check Test by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sa Scientific, Ltd
Sources (1)
- FDA UDI a97ddd23-90f8-44ef-be39-c71e79bc3085 33 fields · synced May 30, 2026