NT9611v3CE

Organization name

Omixon Biocomputing Ltd.

SRN

HU-MF-000003018

Manufacturer status

Active

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• CW010

  2.11 Warnings and precautions Before starting, read all sections of the Warnings and precautions chapter and the safety information for each reagent or kit listed in the Equipment, reagents, and supplies section (see page 8). For advice in event of device malfunction or for useful tips, please visit our FAQ section on the Product support website5. Advisory Notices will be issued and communicated to the users in the case of design changes. Summary of Safety and Performance (SSP) is available on the Omixon website6 until EUDAMED goes live.

Primary placement in Hungary; available across 19 countries total.

Trade name

not provided

UDI-DI code

05999565781378

Basic UDI-DI

599956578001TV

Reference / catalog number

NT9611v3CE

Issuing entity

GS1

Risk category

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

2.2 Intended Purpose The NanoTYPE device group includes 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. The memebers of the device group are single-use, non-automated assays utilizing polymerase chain reaction (PCR) to amplify a list of targeted genes depending on the device model. 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01030499TISSUE TYPING REAGENTS - OTHER

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