VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 04719878570534
- Basic UDI-DI Code
- B-04719878570534
- Reference
- PCRAD1106
- 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 External Control Set is an in vitro diagnostic external run control intended to be used as an aid to verify the performance of VitaSIRO solo™ SARS-CoV-2/Flu/RSV assay. The regular use of external run controls helps laboratories monitor daily test variations, assess the performance of different test kit lots, track individual operator variations, and identify increases in random or systemic errors. The VitaSIRO solo™ SARS-CoV-2/Flu/RSV External Control Set contains in vitro transcribed RNA fragments and should be run in a manner identical to that used for clinical specimens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105080808 | ALL INFECTIOUS DISEASES CONTROLS - NAT |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).