Eu Ivdr
Eu Ivd Class B
On The Market
🇳🇱 Netherlands
RealAccurate® Quadruplex Corona PCR kit
Devices (same UDI-DI)
1
Certificates
0
Countries
1
Notified Bodies
0
Basic Information
- Primary DI
- 08719326569918
- Basic UDI-DI Code
- 87193265699PF0971-R5S
- Reference
- PF0971-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 Corona 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 four coronaviruses: coronavirus 229E, coronavirus OC43, coronaviruses NL63/HKU1. Coronavirus NL63 and HKU1 can be detected, but not differentiated. This test is intended for use on nucleic acids extracted from nasopharyngeal swab samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040519 | CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01] |
Available In Countries
🇳🇱 Netherlands
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).
IDS ACE
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·14 countries
IDS SHBG
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
IDS SHBG Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·27 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
1,25-Dihydroxy Vitamin D RIA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·12 countries
Serum CrossLaps® (CTX-I) ELISA
Device
EU IVDR
·
Eu Ivd Class B
·Immunodiagnostic Systems Limited·On the market·32 countries