H58

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

  Product Use Limitations For the best performance, please use the Holotype HLA 24/7 kit workflow and Omixon HLA Twin software for HLA typing by NGS with the materials, reagents, and equipment recommended in “Equipment, reagents, and supplies” section. Use of materials other than specified in section “Equipment, reagents, and supplies” section must be verified and validated by the user. Do not reconstitute or dilute the reagents in volumes other than described in this IFU. Do not use less volume of the reagents other than specified in this IFU. These activities can lead to performance errors. Omixon cannot provide support for any problems resulting from not following the protocol steps described in this IFU. Do not use the product in case of detectable damage to the components (broken vials, plate, loose caps etc.). Known Product Limitations Please refer to the Known Product Limitations (KPL)document for known ambiguities and known software limitation of the Holotype HLA product. The KPL is bundled with the IFU and also Omixon Holotype HLA 24/7 – Configuration A1/A2/A3/A4 & CE v2 Instructions for Use. For in vitro diagnostic use. Protocol version: v3.0.2; Document version: v5 Copyright© 2023, Omixon Biocomputing Ltd. Confidential & Proprietary Page 8 │ 57 available on the Omixon website under MyHolotype > Support and Services > HLA Twin Instructions for Use, or you can request it from support@omixon.com.

Marché principal en Hongrie ; disponible dans 8 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

05999565780227

Basic UDI-DI

B-05999565780227

Numéro de référence/catalogue

H58

Entité d'attribution

GS1

Catégorie de risque

IVDD — Annexe II Liste B

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

HLA typing Assay by NGS

URL des informations complémentaires

https://www.omixon.com/

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