Genetic Screening Processor

  • 모델명 / 제조번호(시리얼번호)
    Product Code 2021-0010
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including the states of: Missouri, Florida, Texas, Oregon, Alabama, Louisiana, New Jersey, Georgia, Virginia, Kentucky and the countries of: Australia, Belgium, Brazil, Egypt, France, Germany, Italy, Netherlands, Norway, Qatar, Saudi MOH, Switzerland, and the UK.
  • 제품 설명
    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PerkinElmer LAS, Inc, 940 Winter St, Waltham MA 02451-1457
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
  • 제품 설명
    Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 || Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    In-vitro diagnostics - equipment / products for clinical chemistry
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 20210001 through 20210078
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
  • 제품 설명
    Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    2021-0010 | all
  • 제품 설명
    IVD: Laboratory fluorescent immunoassay analyser IVD, semi-automated
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    2021-0010 | see letter
  • 제품 설명
    IVD: Fluorescent immunoassay analyser (FIA), stationary
  • Manufacturer
하나 더 1 건 더