GUDIDData
eudamed_udi Primary ID: 06975424225206

ENA Assay Kit (Fluorescence Immunoassay) (UDI 06975424225206)

Manufactured by DiYaLab ZJG Biotech Co., Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ENA Assay Kit (Fluorescence Immunoassay) - Primary ID 06975424225206

Device Regulatory Overview

The ENA Assay Kit (Fluorescence Immunoassay) (Model/Catalog Number: DL2515301) is a medical device manufactured by DiYaLab ZJG Biotech Co., Ltd. This product is indexed under FDA Product Code / Category Classification W0102100102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
DL2515301
Product Code / EMDN
W0102100102
Device Name
ENA Assay Kit (Fluorescence Immunoassay)
Database Sync Date
2026-08-09 16:49:46

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 ENA Assay Kit (Fluorescence Immunoassay)?

The registered manufacturer of record for ENA Assay Kit (Fluorescence Immunoassay) is DiYaLab ZJG Biotech Co., Ltd.

What is the Primary UDI-DI identifier for ENA Assay Kit (Fluorescence Immunoassay)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06975424225206.

What classification code is assigned to this device?

This device is registered under product classification code W0102100102.

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