INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Basic Information
- Primary DI
- 08800204300232
- Basic UDI-DI Code
- B-08800204300232
- Reference
- RV013F
- 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-RSV 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). The RADI FAST Flu-SC2-RSV Detection Kit qualitatively detects of RNA of Influenza virus and/or S/Orf1ab gene of SARS-CoV-2 and/or N gene of SARS-CoV-2 and/or RSV extracted from nasopharyngeal swab specimens to aid in the diagnosis of Influenza and/or SARS-CoV-2 and/or RSV infection. Among the 4 targets S and Orf1ab genes of SARS-CoV-2 are tagged to single dye (FAM), and N gene is tagged to Cy5.5. Influenza and RSV are tagged to HEX and Cy5 respectively. Positive results are indicative of Influenza and/or SARS-CoV-2 and/or RSV RNA detection, but may not represent the presence of transmissible virus. Negative results do not preclude Influenza and/or SARS-CoV-2 and/or RSV infection and should not be used as the sole basis for patient management decisions. Results must be combined with clinical observations, patient history, and epidemiological information.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070304 | INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] |
Similar Devices
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