GUDIDData
eudamed_udi Primary ID: 06970522642597

Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay) (UDI 06970522642597)

Manufactured by Sichuan Orienter Biotechnology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay) - Primary ID 06970522642597

Device Regulatory Overview

The Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay) (Model/Catalog Number: CA2101) is a medical device manufactured by Sichuan Orienter Biotechnology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021304 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
CA2101
Product Code / EMDN
W01021304
Device Name
Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay)
Database Sync Date
2026-08-09 17:10:46

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 Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay)?

The registered manufacturer of record for Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay) is Sichuan Orienter Biotechnology Co., Ltd..

What is the Primary UDI-DI identifier for Myoglobin (MYO) Assay Kit (Chemiluminescent Immunoassay)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970522642597.

What classification code is assigned to this device?

This device is registered under product classification code W01021304.

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