Device Recall VIDAS Chlamydia kits

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 30101-01, Lot number 868400501.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.
  • 제품 설명
    VIDAS Chlamydia test kits || VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • 제조사 모회사 (2017)
  • Source
    USFDA