Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography) (UDI 06973315736947)
Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.
Device Regulatory Overview
The Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography) (Model/Catalog Number: A4402CV) is a medical device manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W01021311 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- A4402CV
- Product Code / EMDN
- W01021311
- Device Name
- Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)
- Database Sync Date
- 2026-08-09 16:44:50
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 Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)?
The registered manufacturer of record for Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography) is Nanjing Vazyme Medical Technology Co.,Ltd..
What is the Primary UDI-DI identifier for Creatine Kinase MB Isoenzyme (CK-MB) Test Kit (Quantum Dots Fluorescence Immunochromatography)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06973315736947.
What classification code is assigned to this device?
This device is registered under product classification code W01021311.
Similar Classification Devices (W01021311)
Other Devices by Nanjing Vazyme Medical Technology Co.,Ltd.
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