Multi Respiratory Pathogen Real Time PCR Detection Kit
Basic Information
- Primary DI
- 06970895475525
- Basic UDI-DI Code
- B-06970895475525
- Reference
- R23102T2024
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Mole Bioscience Co., LTD.
Additional Description
The Multi Respiratory Pathogen Real Time PCR Detection Kit is non-automated in vitro diagnostic test, based on multiplex real-time PCR, for the qualitative detection and differentiation of 17 types of respiratory pathogens, including 2019-Novel Coronavirus (SARS-CoV-2), Influenza A Virus (IFV A), Influenza B Virus (IFV B), Respiratory Syncytial Virus type A and B (RSV), Rhinovirus type A, B and C(RhV), Coronavirus NL63/229E/OC43/HKU, Enterovirus (EV), Human Metapneumovirus type A and B (hMPV), Human parainfluenza virus 1-4 (hPIV), Adenovirus (Adv/Adv3/Adv7), Epstein-Barr virus(EBV), Bocavirus (BoV), Bordetella pertussis (BP), Mycoplasma pneumonia (MP), and Legionella pneumophila (LP) in the oropharyngeal swab specimens collected from patients or suspected patients with respiratory tract disease. The kit is intended for use as an aid in the detection and differential diagnosis of 17 types of respiratory pathogens in humans in conjunction with clinical and epidemiological risk factors. For professional in-vitro diagnostic use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070503 | RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS |
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