Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
VIROLOGY - NA REAGENTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800204300195
- Basic UDI-DI Code
- B-08800204300195
- Reference
- RV009
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI Flu SC2 Detection Kit is based on Real time RT PCR technology utilizing reverse transcriptase(RT) reaction to convert RNA into complementary DNA (cDNA). It is intended for the presumptive qualitative detection of nucleic acid from the Influenza A virus and/or Influenza B virus and/or SARS-CoV-2 in upper respiratory specimens such as Nasopharyngeal swab, Oropharyngeal swab. The assay is for use by a laboratory professional trained to use real time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040599 | VIROLOGY - NA REAGENTS - OTHER |
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