Hand-held Nucleic Acid Detection Analyzer

Primary DI

16974900600114

Basic UDI-DI Code

697490060SWSI-0243

Reference

SWAI-01

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Zhuhai Shineway Biotech Co.,Ltd

This product can be used with PCR tube for in vitro isothermal nucleic acid amplification detection of the target gene. It is clinically only used with specified IVD reagents (approved by the local medical device management department) for qualitative detection of nucleic acid samples (DNA/RNA) derived from humans. The clinical sample includes throat swabs and nasal swabs from human. Results of the assay are for clinical reference only and shall not be used as the sole basis for diagnosing or excluding cases.

The Basic UDI-DI associated with this device has 5 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).