Eu Ivdd
Eu Ivd Self Testing
On The Market
🇪🇸 Spain
COVID-19 Antigen Rapid Test. Self Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08437022705095
- Basic UDI-DI Code
- B-08437022705095
- Reference
- KASTCOV19-25
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- BIOLAN HEALTH, S.L.
Additional Description
COVID-19 Antigen Rapid Test. Self Test, is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid antigen of SARS-CoV-2 virus in nasal swab samples in only 15-20 minutes. The product is designed as a self-test for lay users.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010699 | CLIN. CHEM. RT & POC - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2022 04 0975 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | 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