Organization name

Vircell, S.L

SRN

ES-MF-000004099

Manufacturer status

Active

Primary placement in Spain; available across 32 countries total.

Trade name

MEASLES REALTIME PCR KIT

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08436610291002

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

843661029RTPCR0360192

Reference / catalog number

RTPCR036-LP

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Real Time RT-PCR kit to detect nucleic acids from measles virus in human saliva or nasopharyngeal swab samples. The device is intended to be used with general population with suspected infection by the microorganism. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.

Additional information URL

https://www.vircell.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0105040704MEASLES - NA REAGENTS

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

No certificate specifically references this device's Basic UDI-DI.