Genedrive® MT-RNR1 Positive Control Kit

Organization name

Genedrive Diagnostics Ltd.

SRN

GB-MF-000012810

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not use past indicated date

  Expired kits should not be used.

Primary placement in EL; available across 5 countries total.

Trade name

Genedrive® MT-RNR1 Positive Control 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.

05060654860325

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.

B-05060654860325

Reference / catalog number

RNR1-CTRL-02

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.

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Genedrive® MT-RNR1 Control Kit is a qualitative molecular test which enables trained healthcare professionals to perform routine QC testing of the Genedrive® System. The Genedrive® MT-RNR1 Control Kit is used in conjunction with the Genedrive® MTRNR1 ID Kit automated on the Genedrive® System. The Genedrive® MT-RNR1 Control Kit tests the ability of the Genedrive System to detect both the wild type and variant for the m.1555A>G single nucleotide polymorphism (SNP) affecting the mitochondrial gene MTRNR1. The Genedrive® MT-RNR1 Control Kit is intended to be used by healthcare professionals within a near patient setting.

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

• IVDD — General medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.