SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM

Primary DI

06974454727582

Basic UDI-DI Code

697445472V22003X033X0348C

Reference

CWX033H-O

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Jiangsu CoWin Biotech Co., Ltd.

Sample Collection Kit is intended for collecting, stabilization and inactivation of human upper respiratory specimens. It consists of Disposable Swab and Viral Sample Preservation Solution (Inactivated). Disposable Collection Swab is designed for collecting specimens. Disposable Collection Swab is individually packaged. There are one and/or two kinds of Disposable Collection Swab in the package. The Type N swab is used for collecting nasopharyngeal (NP) swab, nasal swab (NS), the break point of the nasopharyngeal/nasal swab is far away from swab head. The Type O swab is used for collecting oropharyngeal (OP) swab, and break point of the oropharyngeal swab is closer to the swab head. Viral Sample Preservation Solution (Inactivated) is designed for stabilization and inactivation of specimens at room temperature for up to 1 week. It contains 3 mL solution which is comprised of the following reagents: urea x Sodium dodecyl sulfate (SDS) x TRIS x EDTA x Ethanol (molecular grade) x Nuclease-free water. Sample Collection Kit is intended for use by qualified clinical personnel and in vitro diagnostic procedures.

The Basic UDI-DI associated with this device has 12 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).