Identity
- Trade Name
- Herpes Simplex Negative Control FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Model / Reference
- HSN-3510 FDA UDI
Identifiers
- Catalog Number
- HSN-3510 FDA UDI
- Primary DI / UDI-DI
- B110HSN35100 FDA UDI
- 510(k) Number
- K881261 FDA UDI
- FDA Product Code
- GQO FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control 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 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, controlHerpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control
Herpes Simplex Negative Control by Bion Enterprises, Ltd. — 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 M (IgM) antibody IVD, control.
- Herpes Simplex IgM Control — BION ENTERPRISES, LTD. · Class II
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 Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System — BION ENTERPRISES, LTD.
- Herpes Simplex Type 2 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 1ccd74c3-c910-4724-8673-e1b0f240960e 36 fields · synced May 31, 2026