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Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System FDA UDI
- Generic Name
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent FDA UDI
- Model / Reference
- HS2-4012 FDA UDI
Identifiers
- Catalog Number
- HS2-4012 FDA UDI
- Primary DI / UDI-DI
- B110HS240120 FDA UDI
- 510(k) Number
- K881261 FDA UDI
- FDA Product Code
- GQO FDA UDI
- GMDN Term
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM 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
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
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 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent
Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
K881261 also covers:
- HSV-1 IgG Test System, 120 Tests — BION ENTERPRISES, LTD.
- HSV-2 IgG Test System, 120 Tests — BION ENTERPRISES, LTD.
- Herpes Simplex IgG Control — BION ENTERPRISES, LTD.
- Herpes Simplex IgM Control — BION ENTERPRISES, LTD.
- Herpes Simplex Negative Control — BION ENTERPRISES, LTD.
- Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System — BION ENTERPRISES, LTD.
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
- Bion Enterprises, Ltd.
Sources (1)
- FDA UDI 4a5b8f65-552e-4571-b948-74207babd3df 36 fields · synced Jun 8, 2026