Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975102280107
- Basic UDI-DI Code
- B-06975102280107
- Reference
- 0107
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Suzhou GenDx Biotech Co., Ltd.
Additional Description
The GENEYE® SARS-CoV-2 ERA Assay(Hereinafter called: Assay)is used for in vitro qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in upper respiratory tract specimens (nasopharyngeal extracts) in suspected patients with corona disease (COVID-19). It is considered as a diagnosis aid of COVID-19.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02050399 | NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER |
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