Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06976055490124
Basic UDI-DI Code
B-06976055490124
Reference
NA
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

This product is designed for the in vitro qualitative detection of nucleic acid from Human Parainfluenza Virus (HPIVs) and Adenovirus (HAdV) in throat swabs. The target population is the respiratory tract disease cases suspected of parainfluenza virus and adenovirus infection. This product is an in vitro diagnostic reagent based on real-time fluorescence PCR running on Auto Quantitative PCR System Deaou-ART04. The detection results are only used for clinical auxiliary diagnosis, and cannot be used as the basis for diagnosis or exclusion of cases alone.It is an in vitro diagnostic reagent that utilizes real-time fluorescence PCR, run on Auto Quantitative PCR System Deaou-ART04. The detection results are intended for clinical auxiliary diagnosis only and should not be used as the sole basis for diagnosing or excluding cases.

CND Nomenclature Codes

Code Description
W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

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