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West Nile Virus IgG DxSelect™ - IgG Conjugate

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
West Nile Virus IgG DxSelect™ - IgG Conjugate FDA UDI
Generic Name
West Nile virus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
Model / Reference
EL0304 FDA UDI

Identifiers

Catalog Number
EL0304 FDA UDI
Primary DI / UDI-DI
10816101022318 FDA UDI
510(k) Number
K031953 FDA UDI
FDA Product Code
NOP FDA UDI
GMDN Term
West Nile virus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3940 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: West Nile virus immunoglobulin G (IgG) antibody IVD, reagent

West Nile Virus IgG DxSelect™ - IgG Conjugate by DiaSorin Molecular LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as West Nile virus immunoglobulin G (IgG) antibody IVD, reagent.

Cleared under the same submission

K031953 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI ba6e4753-0216-4a13-9b1e-e8e07b787a56 36 fields · synced Jun 9, 2026