GUDIDData
eudamed_udi Primary ID: 06974521001423

cTnI Assay Kit CLIA (UDI 06974521001423)

Manufactured by Shenzhen Superbio Technology Co.,Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for cTnI Assay Kit CLIA - Primary ID 06974521001423

Device Regulatory Overview

The cTnI Assay Kit CLIA (Model/Catalog Number: SUPM038072) is a medical device manufactured by Shenzhen Superbio Technology Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W01021306 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SUPM038072
Product Code / EMDN
W01021306
Device Name
cTnI Assay Kit CLIA
Database Sync Date
2026-08-09 16:28:51

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 cTnI Assay Kit CLIA?

The registered manufacturer of record for cTnI Assay Kit CLIA is Shenzhen Superbio Technology Co.,Ltd..

What is the Primary UDI-DI identifier for cTnI Assay Kit CLIA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974521001423.

What classification code is assigned to this device?

This device is registered under product classification code W01021306.

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