Basic Information
- Primary DI
- D-5713915CD006LLAP
- Basic UDI-DI Code
- B-5713915CD006LLAP
- Reference
- 8200, 8201
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- PentaBase A/S
Additional Description
RespiDetect™ Respiratory Panel 1 RT-qPCR Assay is a semi-quantitative real-time RT (Reverse Transcriptase) Polymerase Chain Reaction (PCR) assay intended for quantitative detection of RNA from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Influenza (Inf) A, Inf B, and respiratory syncytial virus (RSV) A/B viruses. The assay is used with real-time PCR systems. Viral RNA can be found in the upper or lower respiratory tracts of infected individuals. Samples can be obtained by nasopharyngeal swabs, oropharyngeal swabs, and/or saliva. Samples can be purified on automated platforms or in manual workflows. RespiDetect™ Respiratory Panel 1 RT-qPCR Assay is intended for use by health professionals or qualified laboratory personnel specifically instructed and trained in the techniques of Real-Time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070503 | RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS |
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