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Dengue Virus NS1 Ag ELISA

FDA UDI

Class I (US FDA UDI)

by DRG Instruments Gesellschaft mit beschränkter Haftung

Identity

Trade Name
Dengue Virus NS1 Ag ELISA FDA UDI
Generic Name
Lysozyme (muramidase) 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
04048474060904 FDA UDI
FDA Product Code
JMQ FDA UDI
GMDN Term
Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1490 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA)

Dengue Virus NS1 Ag ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lysozyme (muramidase) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DRG Instruments Gesellschaft mit beschränkter Haftung

Sources (1)

  • FDA UDI 51529e57-ef24-457f-8ee9-3ec1fabceb09 36 fields · synced Jun 7, 2026