Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
SARS-CoV-2 Antigen Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06974487560187
- Basic UDI-DI Code
- B-06974487560187
- Reference
- CP0271-1
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Merlin Biomedical (Xiamen) Co., Ltd.
Additional Description
The cassette is an immunochromatographic lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in nasal swab specimens who are suspected of COVID-19 within seven days of symptom onset and. asymptomatic individuals who have been in contact with confirmed or suspected cases or suspected of having COVID-19 for other epidemiological reasons. The test is intended for home use by laypersons only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. Children and young people under the age of 18 must be supported by parents or authorized adults.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | CeCert/037/W/E.1 | CeCert Sp. z o.o. | Expired |
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