gudid Primary ID: L03A-R0125, L03A-R0135

Flowflex Plus Strep A Rapid Test Strip (UDI L03A-R0125, L03A-R0135)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Flowflex Plus Strep A Rapid Test Strip (Model/Catalog Number: L03A-R0125, L03A-R0135) is a medical device manufactured by Acon Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification GTY 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...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: L03A-R0125, L03A-R0135
Product Code / EMDN: GTY
Device Name: 25 Test per kit (L03A-R0125):Test Strips in pouch (27), Test Tubes (27), Throat Swabs (27), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (1); 25 Test per kit (L03A-R0135): Test Strips in canister (27), Test Tubes (27), Throat Swabs (27), Reagent A (1), Reagent B (1), Positive Control (1), Negative Control (2)
Database Sync Date: 2026-08-09 09:09:51

Full Regulatory Attributes

🔒 Token Gated

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Flowflex Plus Strep A Rapid Test Strip?

The registered manufacturer of record for Flowflex Plus Strep A Rapid Test Strip is Acon Laboratories, Inc..

What is the Primary UDI-DI identifier for Flowflex Plus Strep A Rapid Test Strip?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is L03A-R0125, L03A-R0135.

What classification code is assigned to this device?

This device is registered under product classification code GTY.

Similar Classification Devices (GTY)

Other Devices by Acon Laboratories, Inc.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint