Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719878570312
- Basic UDI-DI Code
- B-04719878570312
- Reference
- PCRAE0128
- 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™ Influenza/SARS-CoV-2 (Flu/SC2) Assay performed on the VitaPCR™ Instrument is a rapid molecular in vitro diagnostic test utilizing a real-time reverse transcription polymerase chain reaction (rRT-PCR) amplification technology. It is used for the simultaneous qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 virus RNAs in direct nasopharyngeal (NP) swabs collected from individuals suspected of respiratory infection along with COVID-19 by their healthcare provider.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070503 | RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries