MYMClass III

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Unknown

MYM is the FDA product code for Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm, a class III device type. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: MYM
Device name: Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code MYM

FDA records hold no clearances under product code MYM.

Recent recalls

Product code MYM

Z-3026-2020Class IIFDA inspection identified that due to increased positivity (false positives) on the Parvovirus B19 ELISA Test System, the firm...Zeus Scientific, Inc. / initiated 2019-08-12 / 74

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)