Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
CORONAVIRUS [obsolete from 2025-01-01]
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800069130067
- Basic UDI-DI Code
- B-08800069130067
- Reference
- R3006
- Device Types
-
Single use Sterile
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SG Medical Inc.
Additional Description
InstaView COVID-19 Antigen is an in vitro diagnostic rapid test for the qualitatively detection of COVID-19 antigen in human nasopharyngeal swab by immune-chromatographic immunoassay. It provides only a screening test result. This product is for professional use only and not intended for personal use. 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] |
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