Eu Ivdd
Eu Ivd General
On The Market
🇹🇼 Taiwan
VitaSIRO solo SARS-CoV-2/Flu/RSV Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 04719878570527
- Basic UDI-DI Code
- B-04719878570527
- Reference
- PCRAD1102
- 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 VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay performed on the automated VitaSIRO solo™ Instrument is a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) in vitro diagnostic test. It is intended for simultaneous qualitative detection and differentiation of nucleic acids from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B), and respiratory syncytial virus (RSV) virus in nasal swab (NS) and nasopharyngeal swab (NP) specimens collected from individuals displaying signs and/or symptoms of respiratory tract infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070302 | OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS |
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