gudid Primary ID: L031-118B5, L031-125M5, L031-125N5, L031-125P5

Flowflex COVID-19 Antigen Home Test (UDI L031-118B5, L031-125M5, L031-125N5, L031-125P5)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Flowflex COVID-19 Antigen Home Test (Model/Catalog Number: L031-118B5, L031-125M5, L031-125N5, L031-125P5) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification QYT within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2322-2015 View Full Alert →

Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the...

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Technical Specifications

Model Number: L031-118B5, L031-125M5, L031-125N5, L031-125P5
Product Code / EMDN: QYT
Device Name: 1 Test per kit (L031-118B5):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L031-125M5): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L031-125N5): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L031-125P5): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Database Sync Date: 2026-08-09 09:17:18

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Flowflex COVID-19 Antigen Home Test?

The registered manufacturer of record for Flowflex COVID-19 Antigen Home Test is Acon Laboratories, Inc..

What is the Primary UDI-DI identifier for Flowflex COVID-19 Antigen Home Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is L031-118B5, L031-125M5, L031-125N5, L031-125P5.

What classification code is assigned to this device?

This device is registered under product classification code QYT.

Similar Classification Devices (QYT)

Other Devices by Acon Laboratories, Inc.

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