Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800204300218
- Basic UDI-DI Code
- B-08800204300218
- Reference
- RV009F
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- KH Medical Co., Ltd.
Additional Description
The RADI FAST Flu-SC2 Detection Kit is an in vitro diagnostic medical device, based on Real-time RT-PCR technology utilizing reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA). This kit 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. The assay is for use by a laboratory professional trained to use real-time PCR in a laboratory.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070399 | MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER |
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