Gluten DQuick Dresolution

Organization name

Clonit srl

SRN

IT-MF-000022196

Manufacturer status

Active

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Trade name

Gluten DQuick Dresolution

UDI-DI code

08057680910688

Basic UDI-DI

B-08057680910688

Reference / catalog number

RT-59v3

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

"The Gluten DQuick DResolution (RT-59v3) is an in vitro nucleic acid amplification test for the detection of the presence of HLA DQ2 (DQ2.2 and DQ2.5), DQ8, DR3, DR4, DR7, DR11 and DR12 haplotypes, by means of Real Time PCR technique. The device specifically detects alleles: HLA DQA1*02, DQA1*03, DQA1*05 - DQB1*02, DQB1*0302 - DRB1*03 - DRB1*04 - DRB1*07 - DRB1*11 - DRB1*12, in samples of DNA extracted from whole peripheral blood collected in EDTA and swab sample. Device is intended to be used for the detection of specific alleles associated with predisposition to a specific condition, intolerance to gluten, for individuals with suspected celiac disease. This kit is for in vitro diagnostics (IVD), for professional use only and not for in vivo use."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106010401HLA-TYPING