Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
VIROLOGY - RT & POC - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800069130081
- Basic UDI-DI Code
- B-08800069130081
- Reference
- R3008
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- SG Medical Inc.
Additional Description
InstaView COVID-19/Flu Ag Combo is an in vitro diagnostic rapid test for the qualitative detection of COVID-19/influenza A/influenza B nucleocapsid antigen in human nasopharyngeal swabs by immune-chromatography assay. It provides only a screening test result. This product is for professional use only and is not intended for personal use. This kit is to aid diagnosis of respiratory diseases (coronavirus/influenza virus infection), but a confirmatory test is required.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
| W0105099004 | INFLUENZA A AND /OR B - RT & POC |
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