A58124

Nom de l'organisation

GeneProof a.s.

SRN

CZ-MF-000002370

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

  EUDAMED n'a pas publié de description pour ce code.

Marché principal en Tchéquie ; disponible dans 2 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

08595696304027

Basic UDI-DI

859569630025QH

Numéro de référence/catalogue

A58124

Entité d'attribution

GS1

Catégorie de risque

IVDR Classe C

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

The intended purpose of the device is related to the medical context and clinical conditions under which the device may be used. Neisseria gonorrhoeae infection can cause cervicitis in women and urethritis in men. In women, the infection can cause pelvic inflammatory disease, ectopic pregnancy and infertility. In men the infection can lead to epididymitis, urethral stricture and infertility. Infants of mothers with gonococcal infection can contract neonatal conjunctivitis, which may lead to blindness. The GeneProof Neisseria gonorrhoeae PCR Kit is an in vitro nucleic acid amplification test intended for detection of N. gonorrhoeae by real-time polymerase chain reaction (PCR) method. The clinical specimens used for the detection are sperm, swabs and urine. The GeneProof Neisseria gonorrhoeae PCR Kit can be used in combination with a manual or automated extraction system. The kit is designed for human in vitro diagnostics and provides qualitative detection. The kit is intended for diagnostics and aid to diagnosis, and it is designed for professional use in laboratories with trained staff.

URL des informations complémentaires

https://thermofisher.com/geneproofIFU

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105010203GONOCOCCAL DETECTION BY NA REAGENTS

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel