Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
FREND Testosterone
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 08809317540375
- Basic UDI-DI Code
- B-08809317540375
- Reference
- FRTEAP 020
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
The FREND Testosterone test is a fluorescent nanoparticle immunoassay designed for in vitro quantitative measurement of total testosterone in human serum and plasma (EDTA and Lithium-heparin). The FREND Testosterone microfluidic flow cartridge is designed for use in the FREND System fluorescent immunoassay reader.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050110 | TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) |
Available In Countries
🇩🇪 Germany
🇪🇸 Spain
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