Device Recall Roche Diagnostics LDL_C

  • 모델명 / 제조번호(시리얼번호)
    Lot 69740501.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03038866322. || An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentrations in serum and plasma.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA