Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
En-swer™ COVID-19 RT-PCR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 08809317540856
- Basic UDI-DI Code
- B-08809317540856
- Reference
- EPCO19100
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- NanoEntek, Inc.
Additional Description
En-swer™ COVID-19 RT-PCR Kit is an in-vitro diagnostic medical device using 1-step RT-qPCR (real-time reverse-transcription polymerase chain reaction) which is a test method that detects genes (the N gene, the E gene) of the novel coronavirus (COVID-19) through qualitative analysis from sputum, nasopharyngeal swab of patients suspected of being infected with the novel coronavirus (COVID-19).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040599 | VIROLOGY - NA REAGENTS - OTHER |
Available In Countries
🇩🇪 Germany
🇷🇴 Romania
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