Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06971792050129
- Basic UDI-DI Code
- B-06971792050129
- Reference
- K751416D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Realy Tech Co.,Ltd.
Additional Description
SARS-Cov-2＆Influenza A/B Combo Rapid Test Cassette (swab) is an in vitro diagnostic test for the qualitative detection of novel coronavirus antigens and influenza A and B antigens in nasal swab from individuals with or without symptoms, using the rapid immunochromatographic method. 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/100/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