Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

GENETIC TESTS - OTHER

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

Basic Information

Primary DI
06948500931797
Basic UDI-DI Code
B-06948500931797
Reference
48 tests/kit
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The kit is used for the qualitative detection of nucleic acids in open reading frame 1ab (ORF1ab), nucleocapsid phosphoprotein (N),envelope protein (E),surface glycoprotein (S) and membrane glycoprotein (M) in SARS-COV-2.This reagent is suitable for the diagnosis or differential diagnosis of suspected cases of pneumonia,suspected clustered cases, and other requiring infection exclusion.The test results are for clinical reference only and can not be used as the basis for confirming or eliminating cases. It is recommended to conduct a comprehensive analysis combining the clinical manifestations of patients and other laboratory tests.

CND Nomenclature Codes

Code Description
W010699 GENETIC TESTS - OTHER

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