Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Monkeypox virus DNA Fluorescence Diagnostic Kit (LAMP)

Sansure Biotech Inc. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06955792730731
Basic UDI-DI Code
B-06955792730731
Reference
S3362E-48
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Sansure Biotech Inc.

Additional Description

Monkeypox is a zoonotic disease caused by monkeypox virus. The incubation period of monkeypox is 5-21 days. The symptoms can be fever, headache, muscle soreness, enlarged lymph nodes and typical pox like herpes. The monkeys first found in central and western Africa can also be transmitted to humans. A positive result of this kit indicates that the patient is infected with a monkeypox virus (MPV) and should promptly consult a hospital or professional institution for re-testing confirmation and treatment. Positive results do not exclude bacterial infection or co-infection with other viruses. The detected pathogen may not be the exact cause of the disease. Negative results do not exclude monkeypox virus (MPV) infection. Negative results must be combined with clinical observations, medical history, and epidemiological information.

CND Nomenclature Codes

Code Description
W0105099099 VIROLOGY - RT & POC - OTHER

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