GastroFinder® 2SMART

Dénomination commerciale

GastroFinder® 2SMART

Code d'IUD-ID

08719327116104

IUD-ID de base

87193271161PF5600-2SVQ

Numéro de référence/catalogue

PF5600-2S

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe B

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

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.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105050208GIARDIA LAMBLIA
• W0105050201ENTAMOEBA HISTOLYTICA
• W0105011606YERSINIA - NA REAGENTS
• W0105011099SALMONELLA REAGENTS - OTHER
• W0105011499CAMPYLOBACTER REAGENTS - OTHER
• W0105011899C.DIFFICILE REAGENTS - OTHER
• W0105040530ASTROVIRUS - NA REAGENTS
• W0105040516NOROVIRUS - NA REAGENTS
• W0105040506ROTAVIRUS - NA REAGENTS
• W0105040501ADENOVIRUS - NA REAGENTS

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• CW010

  Use IFU

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.