Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06930317800670
- Basic UDI-DI Code
- B-06930317800670
- Reference
- DNK-1425-1N
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
Test for self-diagnosis. For in vitro use only. The Dynamiker SARS-CoV-2 Ag Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct from Anterior nostril swab. This test is for home use with self-collected anterior nasal swab samples from individuals aged 15 years or older, or adult-collected anterior nasal swab samples from individuals aged 2 -14 years, without symptoms or within the first 7 days of symptom onset when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/113/W/E.1 | CeCert Sp. z o.o. | Expired |
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