NT9611v3CE

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

  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.

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

Dénomination commerciale

non renseigné

Code d'UDI-DI

05999565781378

Basic UDI-DI

599956578001TV

Numéro de référence/catalogue

NT9611v3CE

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

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.

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