Eu Ivdr
Eu Ivd Class B
On The Market
🇦🇺 Australia
PlexPCR RespiVirus (610)
Devices (same UDI-DI)
3
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 09352224000108
- Basic UDI-DI Code
- 9352224012010WA
- Reference
- 1201001
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- SpeeDx Pty. Ltd.
Additional Description
The PlexPCR RespiVirus kit is an in vitro diagnostic real-time PCR test for the qualitative detection of FluA, FluB, RhV, RSV A and B, HMPV, and HPIV 1-4 RNA and AdV B and C DNA.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070304 | INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01] |
Available In Countries
🇳🇱 Netherlands
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The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.
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