3.154.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

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

• CW265

  The denaturation solution contains < 2% NaOH

Primary placement in Spain; available across 8 countries total.

Trade name

not provided

UDI-DI code

D-84295773154WTGK

Basic UDI-DI

B-84295773154WTGK

Reference / catalog number

3.154.XXX.YY.ZZZ

Issuing entity

EUDAMED

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

TENDED USE The HLA B*27 Strip test allows the determination of the HLA B*27 allele. This group of alleles has been associated with a wide range of pathologies such as ankylosing spondylitis (88-95% of patients), acute anterior uveitis (50-60% of patients), reactive arthritis (60-85% of patients), and inflammatory bowel disease (50-60% of patients). This test is only a tool to help the professionals in the diagnosis of the indicated pathologies. This kit cannot be the only diagnosis tool. The Major Histocompatibility System comprises a set of genes, most of them highly polymorphic, whose products are expressed in a wide range of cells and are responsible for the ‘adaptive’ immune response. These genes are present in all vertebrates and, in humans, they are known as the HLA (Human Leukocyte Antigen) system. The proteins encoded by these genes are called ‘HLA molecules’ or ‘HLA antigens’. The existence of a genetic predisposition to various diseases in individuals carrying the HLA-B*27 histocompatibility antigen has been demonstrated: ankylosing spondylitis, acute anterior uveitis, reactive arthritis, inflammatory bowel disease.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010401HLA-TYPING

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