Device Recall Captia VZV IgG

  • 모델명 / 제조번호(시리얼번호)
    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
  • 제품 설명
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. || For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
  • 제조사 모회사 (2017)
  • Source
    USFDA