AC023/25

Organization name

Nuclear Laser Medicine srl

SRN

IT-MF-000025709

Manufacturer status

Active

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08033629920321

Basic UDI-DI

B-08033629920321

Reference / catalog number

AC023/25

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Cystic Fibrosis is an in vitro diagnostic device intended for the qualitative detection and genotyping of major variants of the CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) gene, from human DNA extracted from whole blood, oral swab and dried blood spot samples. The device provides the material for the identification of the following variants: F508del, I507del, F508C, I502T, 1706del17, 1677delTA, G542X, 1717-1G>A, R553X, Q552X, G551D, S549R(A>C), N1303K, 4016insT, R1162X, R1158X, W1282X, G1244E, 2789+5G>A, 2183AA>G, 711+5G>A, 711+1G>T, G85E, 3849+10kbC>T, 621+1G>T, R117H, D1152H, L1065P, R1066H, L1077P, 4382delA, 1259insA, 852del22, R347P, T338I, S912X, I148T, 3199del6, and Allele 5T (TG9-13; 7T; 9T), through the amplification of target sequences, reverse dot blot on strip and colorimetric detection. The device is a qualitative assay intended for professional use, for manual or semi-automated analytical procedures.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0106010101CYSTIC FIBROSIS