GastroFinder® 2SMART

Primary DI

08719327116104

Basic UDI-DI Code

87193271161PF5600-2SVQ

Reference

PF5600-2S

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

PathoFinder B.V.

Intended Purpose: The GastroFinder® 2SMART (Single tube Multiplex Amplification in Real Time) Kit is a non-automated qualitative multiplex PCR-based test to aid in diagnosis of gastroenteritis in humans by detecting and differentiating 9 species/groups of bacteria, 4 parasites and 5 viruses: Campylobacter spp. (C. jejuni, C. coli, C. lari and C. upsaliensis only, not differentiated), Salmonella spp. (S. enterica and S. bongori only, not differentiated), Yersinia enterolitica, Clostridium difficile toxin A, Clostridium difficile toxin B, Shiga toxin producing E. coli (STEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Shigella / Enteroinvasive E. coli (EIEC) (not differentiated), Entamoeba histolytica, Giardia lamblia, Cryptosporidium spp. (C. parvum, C. hominis C. meleagridis, C. felis and C. canis only, not differentiated), Dientamoeba fragilis, Norovirus (types GI, GII and GIV (not differentiated)), Rotavirus (type A), Adenovirus (types 40 and 41(not differentiated)), Astrovirus and Sapovirus (types GI, GII, GIV and GV (not differentiated)). The GastroFinder® 2SMART® is for use with LightCycler® 480 / cobas® z480 (Roche), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific). Intended user: The product is for use by trained laboratory professionals only. Other laboratory testing and assessment of clinical presentation must be included in the final diagnosis.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).