RespiFinder® 2SMART
Basic Information
- Primary DI
- 08719327116197
- Basic UDI-DI Code
- B-08719327116197
- Reference
- PF2600-2S
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- PathoFinder B.V.
Additional Description
The RespiFinder® 2SMART (Single tube Multiplex Amplification in Real Time) Kit is a non-automated qualitative multiplex PCR test to aid in the diagnosis of respiratory tract infections in humans by detecting and differentiating 18 RNA viruses, 2 DNA viruses as well as 4 bacteria: adenovirus, bocavirus, coronavirus NL63/HKU1, coronavirus OC43, coronavirus 229E, SARS-CoV-2, MERS coronavirus, hMPV, influenza A, influenza B, influenza A H1N1pdm09, parainfluenza 1, parainfluenza 2, parainfluenza 3, parainfluenza 4, rhinovirus/enterovirus, RSV-A, RSV-B, Bordetella pertussis, Chlamydophila pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae. The RespiFinder® 2SMART is for use with LightCycler® 480 / cobas® z480 (Roche) ), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040505 | RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS |
| W0105040502 | ENTEROVIRUS - NA REAGENTS |
| W0105040520 | RHINOVIRUS - NA REAGENTS |
| W0105010503 | LEGIONELLA DETECTION BY NA REAGENTS |
| W0105010803 | MYCOPLASMA DETECTION BY NA REAGENTS |
| W0105010118 | CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS |
| W0105011607 | BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS |
| W0105040504 | INFLUENZA & PARA INFLUENZA - NA REAGENTS |
| W0105040517 | HUMAN METAPNEUMOVIRUS - NA REAGENTS |
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
| W0105040518 | BOCAVIRUS - NA REAGENTS |
| W0105040501 | ADENOVIRUS - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 737648 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).