High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography) (UDI 06979469760579)
Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.
Device Regulatory Overview
The High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography) (Model/Catalog Number: A6403CC) is a medical device manufactured by Nanjing Vazyme Medical 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
- A6403CC
- Product Code / EMDN
- W01021306
- Device Name
- High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography)
- Database Sync Date
- 2026-08-09 16:49:14
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography)?
The registered manufacturer of record for High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography) is Nanjing Vazyme Medical Technology Co.,Ltd..
What is the Primary UDI-DI identifier for High Sensitivity Cardiac Troponin I (hs-cTnI) Test Kit (Quantum Dots Fluorescence Immunochromatography)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06979469760579.
What classification code is assigned to this device?
This device is registered under product classification code W01021306.
Similar Classification Devices (W01021306)
Other Devices by Nanjing Vazyme Medical Technology Co.,Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint