Identity
- Trade Name
- Dengue Virus NS1 Ag ELISA FDA UDI
- Generic Name
- Dengue virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Dengue Virus NS1 Ag ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. FDA UDI
- Model / Reference
- EIA-6090 FDA UDI
- Description
- The Dengue Virus NS1 Ag ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. FDA UDI
Identifiers
- Catalog Number
- EIA-6090 FDA UDI
- Primary DI / UDI-DI
- 00840239060907 FDA UDI
- 510(k) Number
- K181473 FDA UDI
- FDA Product Code
- QCU FDA UDI
- GMDN Term
- Dengue virus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3945 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
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
Category: Dengue virus antigen IVD, kit, enzyme immunoassay (EIA)
Dengue Virus NS1 Ag ELISA by DRG International, Inc. — 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
- DRG International, Inc.
Sources (1)
- FDA UDI 8ad4da17-eab6-46a9-844e-8b968913cb9e 37 fields · synced May 29, 2026