Identity
- Trade Name
- Nano-CheckTM Dengue NS1 FDA UDI
- Generic Name
- Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage. FDA UDI
- Model / Reference
- MD8143 FDA UDI
- Description
- An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage. FDA UDI
Identifiers
- Catalog Number
- MD8143 FDA UDI
- Primary DI / UDI-DI
- 00895160002472 FDA UDI
- FDA Product Code
- OSU FDA UDI
- GMDN Term
- Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3945 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nano-CheckTM Dengue NS1 by Nano-Ditech Corporation — 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
- Nano-Ditech Corporation
Sources (1)
- FDA UDI 5f849588-fdfb-478b-97b9-93c43b719c35 36 fields · synced Jun 9, 2026