← Back to catalogue

IgM Capture Wells

FDA UDI

Class II (US FDA UDI)

by DiaSorin Molecular LLC

Identity

Trade Name
IgM Capture Wells FDA UDI
Generic Name
West Nile virus immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
Model / Reference
EL1521 FDA UDI

Identifiers

Primary DI / UDI-DI
10816101022219 FDA UDI
510(k) Number
K040854 FDA UDI
FDA Product Code
NOP FDA UDI
GMDN Term
West Nile virus immunoglobulin M (IgM) 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

No

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 M (IgM) antibody IVD, reagent

IgM Capture Wells 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 M (IgM) antibody IVD, reagent.

Cleared under the same submission

K040854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DiaSorin Molecular LLC

Sources (1)

  • FDA UDI 5359ffd2-00e9-4d23-bd08-dddab30c9bcd 35 fields · synced Jun 9, 2026