Device Recall ENA6 Screen Enzyme Immunoassay Test Kit

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 720-230
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
  • 제품 설명
    Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" || For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source
    USFDA