eudamed_udi Primary ID: D-ABT-FT-B324

One Step LH Ovulation Test (UDI D-ABT-FT-B324)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The One Step LH Ovulation Test (Model/Catalog Number: ABT-FT-B3) is a medical device manufactured by AccuBioTech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160304 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ABT-FT-B3
Product Code / EMDN: W0102160304
Device Name: One Step LH Ovulation Test
Database Sync Date: 2026-08-09 16:48:19

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 One Step LH Ovulation Test?

The registered manufacturer of record for One Step LH Ovulation Test is AccuBioTech Co., Ltd..

What is the Primary UDI-DI identifier for One Step LH Ovulation Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-ABT-FT-B324.

What classification code is assigned to this device?

This device is registered under product classification code W0102160304.

Similar Classification Devices (W0102160304)

Other Devices by AccuBioTech Co., Ltd.

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