Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay) (UDI 06975424225435)
Manufactured by DiYaLab ZJG Biotech Co., Ltd
Device Regulatory Overview
The Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay) (Model/Catalog Number: DL191201C) is a medical device manufactured by DiYaLab ZJG Biotech Co., Ltd. This product is indexed under FDA Product Code / Category Classification W01021399 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DL191201C
- Product Code / EMDN
- W01021399
- Device Name
- Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)
- Database Sync Date
- 2026-08-09 16:29:10
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)?
The registered manufacturer of record for Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay) is DiYaLab ZJG Biotech Co., Ltd.
What is the Primary UDI-DI identifier for Cardiac Troponin I/Creatine Kinase MB/Myoglobin Assay Kit(Fluorescence Immunoassay)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06975424225435.
What classification code is assigned to this device?
This device is registered under product classification code W01021399.
Similar Classification Devices (W01021399)
Other Devices by DiYaLab ZJG Biotech Co., Ltd
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