Basic Information
- Primary DI
- 09351179001086
- Basic UDI-DI Code
- B-09351179001086
- Reference
- EV002-HT
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Genetic Signatures Ltd
Additional Description
The EasyScreen™ Enteric Viral Detection Kit (EV002) is an in vitro nucleic acid amplification assay for the qualitative detection of Viral DNA and RNA from stool. It comprises a simple and rapid molecular method for the detection of Norovirus GI & GII, Astrovirus, Rotavirus A, Sapovirus, Enterovirus, Bocavirus, Adenovirus and Adenovirus (40 + 41 only) in stool samples. Each reaction also incorporates an Extraction Control to determine the reliability of the extracted DNA and to detect the presence of any inhibitors. The stool sample should first be prepared using EasyScreen™ Sample Processing Kit (SP012). The EasyScreen™ Enteric Viral Detection Kits (EV002) includes all reagents required to detect the specific viral gene sequences using real-time Polymerase Chain Reaction. It is an in vitro diagnostic (IVD) intended as an aid in the diagnosis of gastrointestinal illness. It is intended to be used in a pathology lab or similar, by trained personnel
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070504 | GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS |
Similar Devices
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