Eu Ivdd
Eu Ivd Self Testing
On The Market
🇰🇷 South Korea
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08800069130074
- Basic UDI-DI Code
- B-08800069130074
- Reference
- R3007
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- SG Medical Inc.
Additional Description
InstaView COVID-19 Antigen Home Test is an in vitro diagnostic rapid test for the qualitative detection of COVID-19 Antigen in human nasal/oral swab by immunochromatography assay. This product is intended for home use including self-testing in a non-laboratory setting and over 19 years of age, as an aid to early diagnosis of SARS-CoV-2 infection in individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection. It provides only an initial screening test result. This kit is to aid diagnosis of coronavirus infection, but confirmatory test is required.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040619 | CORONAVIRUS [obsolete from 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-197/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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