GUDIDData
gudid Primary ID: 1

Identify Health HCG Early Pregnancy Rapid Test (UDI 1)

Manufactured by Hangzhou AllTest Biotech Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Identify Health HCG Early Pregnancy Rapid Test - Primary ID 1

Device Regulatory Overview

The Identify Health HCG Early Pregnancy Rapid Test (Model/Catalog Number: 1) is a medical device manufactured by Hangzhou AllTest Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification LCX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
1
Product Code / EMDN
LCX
Device Name
3T, EN non-CE, cut off: 10mIU/Ml
Database Sync Date
2026-08-09 09:04:58

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Identify Health HCG Early Pregnancy Rapid Test?

The registered manufacturer of record for Identify Health HCG Early Pregnancy Rapid Test is Hangzhou AllTest Biotech Co., Ltd..

What is the Primary UDI-DI identifier for Identify Health HCG Early Pregnancy Rapid Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.

What classification code is assigned to this device?

This device is registered under product classification code LCX.

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