Device Recall Captia (TM) Syphilis IgM Capture

  • 모델명 / 제조번호(시리얼번호)
    Lot 033, expiry date 30 November 2014
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    New York, Florida, Utah, and California plus foreign distribution to Spain and France
  • 제품 설명
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Rd, Jamestown NY 14701-9666
  • 제조사 모회사 (2017)
  • Source
    USFDA