Rapid Mycoplasma Pneumoniae IgM test

Dénomination commerciale

Rapid Mycoplasma Pneumoniae IgM test

06936155803835

B-06936155803835

Numéro de référence/catalogue

ITP15001-TC40

GS1

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

Rapid Mycoplasma Pneumoniae IgM Rapid Diagnostic Test Kit is intended for qualitative detection of IgM antibody to Mycoplasma Pneumoniae (MP) in human serum or plasma. Mycoplasma pneumoniae is the smallest and simplest self-replicating bacterium and is a common human pathogen causing upper and lower respiratory tract infections. MP infection may be associated with atypical pneumonia and other respiratory infections, with higher rates observed in autumn and winter. The test is a colloidal gold enhanced rapid immunochromatographic assay. The sample pad is pre-coated with gold-conjugated mouse anti-human IgM monoclonal antibody, the test region is pre-coated with recombinant MP antigen, and the control region is pre-coated with anti-mouse antibody. If MP-IgM is present in the sample, it reacts with the gold conjugate and is captured at the test line to form a colored line. The control line indicates that the test card is valid.

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.

• W0105010802MYCOPLASMA ANTIBODY ASSAYS

4 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  For in vitro diagnostic use only. The test is intended only for detection of MP-IgM in human serum or plasma and provides preliminary analysis results only. Test results should not be used as the only basis for clinical diagnosis. Perform the test under controlled conditions, avoid high humidity and high temperature, use a new and clean plastic pipette to avoid cross-contamination, and do not interpret results after 20 minutes.
• CW010

  Read the package insert carefully before use and strictly follow the instructions.
• CW008

  For testing suspected infected samples, conduct testing within a biosafety cabinet where appropriate. Wear gloves, do not transfer samples by mouth, do not smoke, eat, drink, put on make-up or handle contact lenses during testing, disinfect spilled samples or reagents, and handle and dispose of samples and used materials according to applicable regulations.; Do not re-use: This is a single-use rapid test. Do not re-use the test kit.
• CW009

  Do not use expired test kits.