3.165.XXX.YY.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

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

• CW265

  The denaturation solution contains < 2% NaOH

Marché principal en Espagne ; disponible dans 4 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295773165WYH9

Basic UDI-DI

B-84295773165WYH9

Numéro de référence/catalogue

3.165.XXX.YY.ZZZ

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 S. PneumoStrip test is a test based on the reverse blot technique that allows the identification, in base of its genetic sequence, of 76 serotypes of S. pneumoniae: • Strip A: 1, 3, 4, 5, 6A, 6B, 6C, 6D, 7F/7A, 9A/9V, 14, 18A, 18B/18C, 18F, 19A, 19F, 23A, 23B, 23 F. • Strip B: 2, 8, 9N/9L, 10A, 10B, 10F/C, 11A/D, 11B, 11C, 11F, 12A/46, 12B/44, 12F, 15B/15C, 17F, 20, 22F/22A, 33F/33A, 37. • Strip C: 7B, 7C/40, 15A, 15F, 16F, 19B/19C, 21, 25A/25F, 38, 24A, 24B/24F, 31, 32A/32F, 33B/33D, 33C, 35A, 35C, 35F, 47F, 41A, 41F. Of the 76 serotypes, 42 are identified individually and 34 as pairs (for example, the presence of serotypes 7F or 7A). The S. PneumoStrip kit is based on the principle of reverse hybridization, and allows the detection and identification of DNA samples, extracted from bacterial culture, of 76 serotypes of S. pneumoniae. Infections of S. pneumoniae represent an important public health problem in both industrialized nations as well as those that are less-developed. It is responsible for high mortality and lethality, as it is one of the main causative agents for a large variety of clinical conditions, from benign infections like otitis media and acute sinusitis to more severe infections such as septicaemia, meningitis and pneumonia.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0105011105STREP. PNEUMONIAE DETECTION BY NA REAGENTS

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