Device Recall MicroVue BAP EIA, Model 8012

  • 모델명 / 제조번호(시리얼번호)
    Lot 067850
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
  • 제품 설명
    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
  • 제조사 모회사 (2017)
  • Source
    USFDA