1292380000

Organization name

Progenika Biopharma, S.A.

SRN

ES-MF-000001005

Manufacturer status

Active

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• CW018

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Primary placement in Spain; available across 5 countries total.

Trade name

not provided

UDI-DI code

08437013457095

Basic UDI-DI

8437013457Gentest001QK

Reference / catalog number

1292380000

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200TM instrument (with xPONENT® software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect·Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Additional information URL

https://techdocs.grifols.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

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