Eu Ivdd
Eu Ivd General
On The Market
🇪🇸 Spain
COVID-19 lgG/IgM Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08437022705019
- Basic UDI-DI Code
- B-08437022705019
- Reference
- KSCOV19
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- BIOLAN HEALTH, S.L.
Additional Description
BIOLAN HEALTH´s COVID-19 lgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of lgG and lgM antibodies against SARS-CoV-2, in human whole blood, serum or plasma, in only 5-10 minutes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
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