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Instructions for Use Please read before using this product. Mode d’Emploi Á lire avant d’utiliser ce produit. Istruzioni per l’uso Si prega di leggere, prima di usare il prodotto. Gebrauchsanweisung Bitte vor der V erwendung dieses Produkts lesen. Instrucciones de Uso Por favor , leer antes de utilizar este producto. Instruções de Utiliza?[...]
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P A0027 Page 1[...]
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P A0027 Page 2 Intended Use This reagent is for in vitro diagnostic use. Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identication by light microscopy of human HMB45 antigen in formalin-xed, parafn-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpre[...]
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P A0027 Page 3 • Consult Federal, State or local regulations for disposal of any potentially toxic components. • Minimize microbial contamination of reagents or an increase in non-specic staining may occur . • Retrieval, incubation times or temperatures other than those specied may give erroneous results. Any such change must be validat[...]
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P A0027 Page 4 Utilisation Prévue Ce réactif est destiné au diagnostic in vitro. L ’anticorps monoclonal Melanoma Marker (HMB45) est destiné à l’identication qualitative par microscopie optique de l’antigène humain HMB45 dans des tissus xés au formol et enrobés de parafne par coloration immunohistochimique à partir d’un sy[...]
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P A0027 Page 5 • Pour obtenir un exemplaire de la che technique des substances dangereuses (Material Safety Data Sheet), contactez votre distributeur local ou le bureau régional de Leica Biosystems, ou consultez le site Web de Leica Biosystems : www .LeicaBiosystems.com • Les échantillons, avant et après xation, et tous les matériels [...]
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P A0027 Page 6 Uso previsto Reagente per uso diagnostico in vitro. L ’anticorpo monoclonale Melanoma Marker (HMB45) deve essere utilizzato per l’identicazione qualitativa tramite microscopio ottico dell’antigene umano HMB45 in tessuto ssato in formalina, incluso in parafna tramite colorazione immunoistochimica con un sistema Bond aut[...]
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P A0027 Page 7 • I campioni, prima e dopo la ssazione, e tutti i materiali esposti ad essi devono essere manipolati come potenziali vettori di infezione e smaltiti con le opportune precauzioni 2 . Non pipettare mai i reagenti con la bocca ed evitare il contatto dei reagenti e dei campioni con la cute e le mucose. Se un reagente o un campione v[...]
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P A0027 Page 8 V erwendungszweck Dieses Produkt ist für die In-vitro-Diagnostik bestimmt. Der monoklonale Antikörper Melanoma Marker (HMB45) ist für die qualitative lichtmikroskopische Identizierung des humanen HMB45-Antigens in formalinxiertem, in Parafn eingebettetem Gewebe durch immunhistochemische Färbung mithilfe eines Bond- Färb[...]
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P A0027 Page 9 • Ein Exemplar des Sicherheitsdatenblattes erhalten Sie von Ihrer örtlichen V ertriebsrma, von der Regionalniederlassung von Leica Biosystems oder über die Webseite von Leica Biosystems unter www .LeicaBiosystems.com • Behandeln Sie Präparate vor und nach der Fixierung sowie sämtliche damit in Berührung kommenden Material[...]
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P A0027 Page 10 Indicaciones de Uso Este reactivo es para uso diagnóstico in vitro. El anticuerpo monoclonal Melanoma Marker (HMB45) está pensado para su utilización en la identicación cualitativa mediante microscopía ligera del antígeno humano HMB45 en tejido jado en formol y embebido en parana mediante tinción inmunohistoquímica [...]
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P A0027 Page 11 • Las muestras, antes y después de ser jadas, y cualquier material en contacto con ellas, deben ser tratados como sustancias capaces de transmitir infecciones y deben desecharse con las precauciones correspondientes 2 . No pipetee nunca los reactivos con la boca, y evite el contacto de la piel y las mucosas con reactivos o mue[...]
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P A0027 Page 12 Utilização Prevista Este reagente destina-se a utilização diagnóstica in vitro. O anticorpo monoclonal Melanoma Marker (HMB45) está previsto para ser utilizado para a identicação qualitativa por microscopia óptica do antigénio HMB45 humanizado em tecido impregnado em parana e xado em formalina, por coloração imu[...]
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P A0027 Page 13 • As amostras, antes e depois da xação, e todo o material que a elas seja exposto, devem ser manipulados como se fossem capazes de transmitir infecção e eliminados usando as precauções adequadas 2 . Nunca pipete reagentes com a boca e evite o contacto entre a pele e membranas mucosas com reagentes ou amostras. Se reagente[...]
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P A0027 Page 14 Användningsområde Reagenset är avsett för in vitro-diagnostik. Melanoma Marker (HMB45) monoklonal antikropp är avsedd att användas för kvalitativ identiering med ljusmikroskopi av mänskliga HMB45-antigener i formalinxerad, parafninbäddad vävnad med hjälp av immunohistokemisk infärgning med ett automatiserat Bond[...]
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P A0027 Page 15 • Prover , både före och efter xering, samt all materiel som exponeras för dem, bör behandlas och avfallshanteras som potentiellt smittbärande material 2 . Munpipettera aldrig reagens och undvik att hud eller slemhinnor kommer i kontakt med reagens eller prover . Om reagens eller prover skulle komma i kontakt med känsliga[...]
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P A0027 Page 16 Σκο πός Χρήσης Αυτό το αντιδραστήριο προορίζ εται για in vitro διαγνωστική χρήση. Τ ο μονοκλωνικό αντίσωμα Melanoma Marker (HMB45) προορίζεται για την π οιοτική ταυτο ποίηση (μέσω μικροσκοπίας φωτ?[...]
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P A0027 Page 17 • Αν θέλετε ένα αντίγραφο του Material Safety Data Sheet [Δελτίο Δεδομένων Ασφαλείας Υλικού], επικοινωνήστε με τον αντιπρόσωπ ο ή το περιφερειακό γραφείο της Leica Biosystems, ή εναλλακτικ ά, επισκεφθεί?[...]
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P A0027 Page 18 Bond ™ Brugsklart Primaert Antistof Melanoma Marker (HMB45) Katalognummer .: P A0027 Tilsigtet Anvendelse Dette reagens er beregnet til in vitro diagnostik. Monoklonalt antistof til Melanoma Marker (HMB45) er beregnet til kvalitativ identicering med lysmikroskopi af humant HMB45-antigen i formalinkseret, parafnindlejret v[...]
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P A0027 Page 19 • Bortskaffelse af potentielt toksiske komponenter skal ske i overensstemmelse med gældende statslig eller lokal lovgivning. • Mikrobiel kontaminering af reagenser skal minimeres for at undgå en øget uspecik farvning. • Gennding og inkubationstider eller temperaturer , som afviger fra de specicerede, kan give fejla[...]
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Leica Biosystems Newcastle Ltd Balliol Business Park West Benton Lane Newcastle Upon T yne NE12 8EW United Kingdom ( +44 191 215 4242 © Leica Biosystems Newcastle Ltd • 95.7947 Rev B • PA0027 09/05/2013[...]