Eu Ivdr
Eu Ivd Class B
On The Market
🇳🇱 Netherlands
RealAccurate® Quadruplex Bordetella PCR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719326569970
- Basic UDI-DI Code
- 87193265699PF0975-R6E
- Reference
- PF0975-R
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- PathoFinder B.V.
Additional Description
Intended purpose: RealAccurate® Quadruplex Bordetella PCR Kit is a non-automated, qualitative multiplex real-time PCR-based test to aid the diagnosis of respiratory infections in humans, by detecting and differentiating within 2 hours: Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii. This test is intended for use on nucleic acids extracted from nasopharyngeal swab samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105011607 | BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS |
Available In Countries
🇳🇱 Netherlands
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