NT4x9611CE

Nom de l'organisation

Omixon Biocomputing Ltd.

SRN

HU-MF-000003018

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  see IFU 2.11 Warnings and precautions section

Marché principal en Belgique ; disponible dans 19 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05999565781323

Basic UDI-DI

599956578001TV

Numéro de référence/catalogue

NT4x9611CE

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe C

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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]

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01030499TISSUE TYPING REAGENTS - OTHER

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel