Organization name

ElitechGroup S.p.A.

SRN

IT-MF-000005919

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Italy; available across 32 countries total.

Trade name

HCV ELITe MGB® 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.

08033891487072

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.

803389148HCV38BV

Reference / catalog number

RTK601ING

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 D

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The product HCV ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids reverse transcription and Real-Time PCR assayfor the detection and quantification of the RNA of Hepatitis C Virus (HCV), extracted from clinical specimens.

Additional information URL

https://www.elitechgroup.com/documentation/

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.

• W0105020307HEPATITIS C VIRUS - NA REAGENTS

• IVDR Class D medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.