Monkeypox Virus Real Time PCR Kit

Primary DI

06936595752304

Basic UDI-DI Code

B-06936595752304

Reference

YG2014Y

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

MedicalSystem Biotechnology Co., Ltd.

The Monkeypox Virus Real Time PCR Kit is a reagent system, based on the real-time polymerase chain reaction (qRT-PCR) technology, for the in vitro qualitative detection of monkeypox virus specific DNA in human serum, plasma or rash exudate. The primer and probe sets are designed for specific detection of monkeypox virus (F3L gene). This test is intended for use as an aid in the diagnosis of monkeypox virus infection in the humans. Negative results do not preclude monkeypox virus infection, and should not be used as the sole basis for treatment or other patient management decisions.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).