

# MYM · Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MYM

## Overview

- **Product Code:** MYM
- **Device Name:** Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P250039](/device/P250039.md) | LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus | DiaSorin, Inc. | May 7, 2026 | APPR |
| [P150042](/device/P150042.md) | ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM | Zeus Scientific, Inc. | Sep 19, 2017 | APPR |
| [P970055](/device/P970055.md) | BIOTRIN PARVOVIRUS IGM EIA (V619IMUS) | Diasorin | Aug 6, 1999 | APPR |

## Top Applicants

- DiaSorin, Inc. — 1 clearance
- Diasorin — 1 clearance
- Zeus Scientific, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/MYM](https://fda.innolitics.com/productcode/MYM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
