Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
VitaPCR SARS-CoV-2 Gen 2 Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719878570220
- Basic UDI-DI Code
- B-04719878570220
- Reference
- PCRAE0120
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch
Additional Description
The VitaPCR™ SARS-CoV-2 Gen 2 Assay performed on the VitaPCR™ Instrument is a rapid molecular in vitro diagnostic test utilizing a real-time reverse transcription polymerase chain reaction (RT-PCR) amplification technology for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal (NP) or oropharyngeal (OP) swabs from patients who are suspected of COVID-19 by their healthcare providers.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105041106 | CORONAVIRUS - NA REAGENTS |
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