Device Recall Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent

  • 모델명 / 제조번호(시리얼번호)
    1 mL vial, Product Code CD7-580-L-CE, lot numbers L158019 and L158020;  0.1 mL vial, Product Code CD7-580-L-CE-S, lot number L158018
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) and the country of Canada.
  • 제품 설명
    Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. || NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of CD7 molecules in paraffin-embedded tissue by immunohistochemical staining.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Leica Microsystems, Inc., 1700 Leider Ln, Buffalo Grove IL 60089-6622
  • 제조사 모회사 (2017)
  • Source
    USFDA