NanoTYPE 4x96/11 CE

Primary DI

05999565781323

Basic UDI-DI Code

599956578001TV

Reference

NT4x9611CE

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Omixon Biocomputing Ltd.

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]

The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).