Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P) (UDI D-CMCT431VF)
Manufactured by Hangzhou Clongene Biotech Co., Ltd.
Device Regulatory Overview
The Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P) (Model/Catalog Number: CMCT4312) is a medical device manufactured by Hangzhou Clongene Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160706 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CMCT4312
- Product Code / EMDN
- W0102160706
- Device Name
- Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)
- Database Sync Date
- 2026-08-09 16:30:31
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 Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)?
The registered manufacturer of record for Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P) is Hangzhou Clongene Biotech Co., Ltd..
What is the Primary UDI-DI identifier for Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CMCT431VF.
What classification code is assigned to this device?
This device is registered under product classification code W0102160706.
Similar Classification Devices (W0102160706)
Other Devices by Hangzhou Clongene Biotech Co., Ltd.
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