Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

VIROLOGY - NA REAGENTS - OTHER

Daan Gene Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06928103009314
Basic UDI-DI Code
B-06928103009314
Reference
DA0931
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Daan Gene Co., Ltd.

Additional Description

This kit is used for in vitro qualitative detection of the ORF1ab and N genes of novel coronavirus (2019-nCoV) from throat swabs and sputum samples in pneumonia suspected cases of novel coronavirus infection, patients with suspected cluster cases, and other patients requiring diagnosis or differential diagnosis of novel coronavirus infection. The test results of this kit are for clinical reference only and should not be used as the sole criterion for clinical diagnosis. It is recommended to conduct a comprehensive analysis of the condition in combination with the clinical manifestations of the patient and other laboratory tests.

CND Nomenclature Codes

Code Description
W0105040599 VIROLOGY - NA REAGENTS - OTHER

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