Device Recall Sm ELISA Test System

  • 모델명 / 제조번호(시리얼번호)
    Lot number 08041819, Exp. 11/2009;, Lot number 08041811, Exp. 11/2009 (Inverness Medical - Wampole)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Sm ELISA Test System || Product number 2Z2831G and Product number 43270CE || Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. || Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. || Also manufactured for Wampole Laboratories, Princeton, NJ 08540 || Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zeus Scientific Inc, 200 Evans Way, Somerville NJ 08876-3767
  • Source
    USFDA