Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
EZER Flu & COVID-19 Antigen Duo Rapid Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 16972698600811
- Basic UDI-DI Code
- B-16972698600811
- Reference
- P213107
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
Additional Description
It is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B from nasal swab specimens. (5 tests/kit)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070599 | MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-261/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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