Holotype HLA 96/7 – Configuration A & CE v2

Organization name

Omixon Biocomputing Ltd.

SRN

HU-MF-000003018

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• 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 available on the Omixon website under MyHolotype > Support and Services > HLA Twin Instructions for Use, or you can request it from support@omixon.com.

Primary placement in France; available across 8 countries total.

Trade name

Holotype HLA 96/7 – Configuration A & CE v2

UDI-DI code

05999565780678

Basic UDI-DI

B-05999565780678

Reference / catalog number

H32.1

Issuing entity

GS1

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

HLA typing Assay by NGS

Additional information URL

https://www.omixon.com/

Clinical sizes

No clinical sizes registered for this device.

• W010699GENETIC TESTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification