Identity
- Trade Name
- biokitHSV-2 FDA UDI
- Generic Name
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary tubes 20 x Lancets 20 x Swabs 20 x Tube racks FDA UDI
- Model / Reference
- 300028001 FDA UDI
- Description
- 20 Test Devices 20 x 0,7 ml Sample Diluent 20 x 0,5 ml Developing Reagent 20 x Empty Vials 1 20 x Pre-filter tips 20 x Capillary tubes 20 x Lancets 20 x Swabs 20 x Tube racks FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426951056439 FDA UDI
- FDA Product Code
- LGC FDA UDI
- GMDN Term
- Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 FDA UDI
- Commercial Distribution
- Not 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
biokitHSV-2 by Biokit, S.a. — Class II — 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biokit, S.a.
Sources (1)
- FDA UDI 7f424a0f-e9cc-4126-bfaa-c5c7a895a1f9 35 fields · synced May 30, 2026