ClinEasy®

Nom de l'organisation

RECIPE Chemicals + Instruments GmbH

SRN

DE-MF-000032553

Statut du fabricant

Actif

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

• CW018

  See IFU Section 2.1.3 - 2.1.5

Marché principal en Allemagne ; disponible dans 1 pays au total.

Commercialisé en Allemagne ; dates par pays non publiées.

Dénomination commerciale

ClinEasy®

Code d'UDI-DI

D-17x00RL

Basic UDI-DI

B-17x00RL

Numéro de référence/catalogue

17200

Entité d'attribution

EUDAMED

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The ClinEasy® Complete Kit with order no. 17200 is intended for the photometric quantitative determination of 5-Aminolevulinic Acid (5-ALA) and Porphobilinogen (PBG) in native human urine. The ClinEasy® Complete Kit with order no. 17300 is intended for the sole photometric quantitative determination of Porphobilinogen (PBG) in native human urine. Both kits are not intended for porphyria screening, monitoring, or diagnosis, prognosis, prediction or companion diagnostics. Test results are intended to determine a (patho-)physiological state to be used as an aid in diagnosis of porphyrias. Test results indicating a pathological urine concentration need further laboratory and diagnostic activities at the discretion of the treating clinician/medical doctor. In line with the explanations provided in section 1.5 (Clinical Background) test results may require additional analytical and diagnostic activities. Those are described in guidance documents provided by national and international expert panels such as the European Porphyria Network (EPN) [1] or the Best Practice Guidelines (BPG) [2] issued by the ACB (The Association for Clinical Biochemistry and Laboratory Medicine). The testing population for both kits are patients with clinical symptoms which may be in relation with porphyria. There are no restrictions regarding age, sex or ethnicity. The components of both complete kits have to be used in accordance with this user manual and in combination with other components provided by RECIPE. The complete kits are not designed for combination with components of other manufacturers. Both kits are intended for application on qualified spectrophotometers by professional clinical laboratories. The analytical methods are not intended for automation.

URL des informations complémentaires

https://recipe.de/de/myrecipe

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W01010209DELTA-AMINOLAEVULINIC ACID

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