Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
Flowflex SARS-CoV-2 Antigen Rapid Test(Self-Testing)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-L031-118Y5N3
- Basic UDI-DI Code
- B-L031-118Y5N3
- Reference
- L031-118Y5
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Acon Biotech (Hangzhou) Co., Ltd.
Additional Description
The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. The test can also test specimens from individuals without symptoms. It is intended to be used for self-testing by lay users as an aid to diagnosis of SARS-CoV-2 infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | V9 042074 0032 | TÜV SÜD Product Service GmbH | Expired |
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