Eu Ivdd Eu Ivd General On The Market 🇰🇷 South Korea

DENGUE VIRUS - NA REAGENTS

KH Medical Co., Ltd. · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
08800204300164
Basic UDI-DI Code
B-08800204300164
Reference
RV002
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
KH Medical Co., Ltd.

Additional Description

The RADI Dengue Virus Detection KIT is an in vitro diagnostic medical device, based on Real-time RT-PCR technology to detect the Dengue Virus RNA. The kit is intended for the presumptive qualitative detection of nucleic acid extracted from the Dengue virus in human serum specimens obtained from patients with signs and symptoms of Dengue. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.

CND Nomenclature Codes

Code Description
W0105040511 DENGUE VIRUS - NA REAGENTS

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