Organization name

Omixon Biocomputing Ltd.

SRN

HU-MF-000003018

Manufacturer status

Active

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

• Consult instructions for use

  see IFU 2.11 Warnings and precautions section

Primary placement in Belgium; available across 19 countries total.

Trade name

NanoTYPE 4x96/11 CE

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.

05999565781323

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.

599956578001TV

Reference / catalog number

NT4x9611CE

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

Intended Use: NanoTYPE is a family of qualitative in vitro diagnostic medical devices intended for the identification and definition of Class I (A, B, and C) and Class II (DQA1, DQB1, DRB1, DRB3/4/5, DPA1, DPB1) genes of the Human Leukocyte Antigens (HLA) complex from human genomic DNA derived from human whole blood. It is a singleuse, non-automated assay utilizing polymerase chain reaction (PCR) to amplify a list of targeted genes depending on the product configuration. The generated amplicons are intended for a downstream library preparation and sequencing by Oxford Nanopore Technologies reagents and platforms in order to generate data for high resolution HLA genotyping using the Omixon NanoTYPER software. The assay results are intended to provide an HLA profile of the tested individual which can be used as an aid in assessment of the HLA gene compatibility between the patient and the donor population for the transplantation purposes. Intended Users: NanoTYPE is intended for in vitro diagnostic use by professional healthcare personnel, such as laboratory technicians and physicians, trained in the techniques of molecular and in vitro diagnostic procedures as well as in HLA typing in diagnostic laboratories either EFI or ASHI accredited or able to work according to EFI or ASHI specifications. [EN]

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.

• W01030499TISSUE TYPING REAGENTS - OTHER

• IVDR Class C medical devices in EUDAMED

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