Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Novel Coronavirus（SARS-Cov-2）Antigen Rapid Test Device（saliva）
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06971792050051
- Basic UDI-DI Code
- B-06971792050051
- Reference
- K590516D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
This kit is intended for the qualitative detection the N protein of SARS-CoV-2 antigens in human saliva specimens from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection.It is used for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/036/W/E.1 | CeCert Sp. z o.o. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEK™ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEK™ Lactate Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
BGI
Device
EU IVDD
·
Eu Ivd Self Testing
·BGI EUROPE A/S·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market