Perkinelmer

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 20 건

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
  • 의료기기 분류등급
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Microplate, truncated V-bottomed lots included in the || above listed products || Product Number: 1380 5465. || DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 618201, 619200, 618263
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    NEONATAL TOTAL GALACTOSE KIT || Product Numbers: 3029-0010, 3029-001B. || This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
  • 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.
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 617341, 619236
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM || MASS SPECTROMETRY KIT || Product Number: 3026-0030. || This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
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