RealAccurate® Quadruplex SARS-CoV-2 PCR Kit

Organization name

PathoFinder B.V.

SRN

NL-MF-000002704

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Use IFU

Primary placement in Netherlands; available across 1 country total.

Trade name

RealAccurate® Quadruplex SARS-CoV-2 PCR Kit

UDI-DI code

08719327497906

Basic UDI-DI

B-08719327497906

Reference / catalog number

PF0971C-R

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

RealAccurate® Quadruplex SARS-CoV-2 PCR Kit is a non-automated qualitative multiplex real-time PCR-based test to aid the diagnosis of respiratory infections in humans, by detecting within 2 hours Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19)), using 2 different genes: Nucleocapsid protein (N) gene and RNA-dependent RNA polymerase (RdRp). This test is intended for use on nucleic acids extracted from nasopharyngeal swab samples.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105040519CORONAVIRUS - NA REAGENTSInactive