NWYNot classified

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

Unknown

NWY is the FDA product code for Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies. FDA's definition for this code reads: "Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code: NWY
Device name: Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
FDA definition: Intended for the detection of IgM and IgG antibodies to dengue virus in human serum, plasma or whole blood.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 2

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NWY

FDA records hold no clearances under product code NWY.

Recent recalls

Product code NWY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)