Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND Cardiac Triple
Devices (same UDI-DI)
1
Certificates
0
Countries
8
Notified Bodies
0
Basic Information
- Primary DI
- 08809317540078
- Basic UDI-DI Code
- B-08809317540078
- Reference
- FRCT 025
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
The FREND Cardiac Triple test is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of myoglobin, troponin I, and creatine kinase MB in human plasma samples using EDTA as the anticoagulant. The FREND Cardiac Triple microfluidic flow cartridge is designed for use in the FREND System to aid in the diagnosis and assessment of the severity of myocardial infarction.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021311 | CREATINE KINASE - MB MASS (IC) |
| W01021306 | TROPONIN I/T |
| W01021304 | MYOGLOBIN |
Available In Countries
🇨🇾 Cyprus
🇩🇪 Germany
🇪🇸 Spain
🇭🇺 Hungary
🇮🇹 Italy
🇱🇹 Lithuania
🇷🇴 Romania
🇹🇷 Türkiye
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