VIROLOGY - NA REAGENTS - OTHER
Basic Information
- Primary DI
- 08800204300072
- Basic UDI-DI Code
- B-08800204300072
- Reference
- RV008F
- 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 COVID-19 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 COVID-19 Detection Kit qualitatively detects of RNA of S gene, Orf1ab gene, N gene and E gene of SARS-CoV-2 extracted from nasopharyngeal and oropharyngeal swab specimens to aid in the diagnosis of SARS-CoV-2 infection. Among the 4 genes S and Orf1ab genes are tagged to single dye (FAM), and the other N and E genes are tagged to two separate dyes HEX and Quasar705 respectively. Positive results are indicative of SARS-CoV-2 RNA detection, but may not represent the presence of transmissible virus. Negative results do not preclude SARS-CoV-2 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 |
|---|---|
| W0105040599 | VIROLOGY - NA REAGENTS - OTHER |
Similar Devices
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