Interpretive software IVDs

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Grifols Australia Pty Ltd

classe:

Class 3

Fabriqué par:

Progenika Biopharma SA Parque Tecnologico de Bizkaia Ibaizabl bidea Edificio 504, Derio, 48160 Spain

Domaine thérapeutique:

CT910 - Interpretive software IVDs

indications thérapeutiques:

A1AT Genotyping Test ANALYSIS SOFTWARE used in A1AT genotyping kit which 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. 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).

Statut de autorisation:

A

Date de l'autorisation:

2021-08-19