Device Recall Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. || This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • 제조사 모회사 (2017)
  • Source
    USFDA