Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)

Primary DI

06972665701148

Basic UDI-DI Code

B-06972665701148

Reference

Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

Device Types

Single use Sterilization

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

XIAMEN SPACEGEN CO.,LTD.

The kit is a real-time PCR assay for qualitative detection of Monkeypox virus (MPXV). It is intended to use with viral DNA extracted from whole blood, serum, Oropharyngeal swab, nasopharyngeal swab, or skin lesion material including pustular or vesicular rash, swabs of lesion surface and/or exudate, lesion roofs, or lesion crusts. The test results should not be used as the sole basis for patient management decisions. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.

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