ADVIA 2400 Chemistry System

  • 모델명 / 제조번호(시리얼번호)
    All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • 제품 설명
    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591-5097
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide including USA and Puerto Rico.
  • 제품 설명
    Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 01803350 (Lot serial: CA12430054); Model Catalog: 01803350 (Lot serial: CA12420093); Model Catalog: 01803350 (Lot serial: CA12440092); Model Catalog: 01803350 (Lot serial: CA12440048); Model Catalog: 01803350 (Lot serial: CA12440035); Model Catalog: 01803350 (Lot serial: CA12440034); Model Catalog: 01803350 (Lot serial: CA12430055); Model Catalog: 01803350 (Lot serial: CA12430022); Model Catalog: 01803350 (Lot serial: CA12310054); Model Catalog: 01803350 (Lot serial: CA12310055); Model Catalog: 01803350 (Lot serial: CA12320089); Model Catalog: 01803350 (Lot serial: CA12310091); Model Catalog: 01803350 (Lot serial: CA12320016); Model Catalog: 01803350 (Lot serial: CA12320015); Model Catalog: 01803350 (Lot serial: CA12320088); Model Catalog: 01803350 (Lot serial: CA12340052); Model Catalog: 01803350 (Lot serial: CA12320093); Model Catalog: 01803350 (Lot serial: CA12300004); Model Catalog: 01803350 (Lot serial: CA12310069); Model Catalog: 01803350 (Lot serial: CA12310068); Model Catalog: 01803350
  • 제품 설명
    ADVIA 2400 TOTAL PROTEIN II (TP) ASSAY
  • Manufacturer
하나 더 2 건 더