Quality control material

제조사

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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  • 모델명 / 제조번호(시리얼번호)
    Part Number 94413. Lot Number C2681A.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
  • 제품 설명
    Alere Triage¿ TOX Drug Screen Control 1 || Product Generic Name: Quality Control Material || Description of the product: || Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment || of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control || procedures. The Alere Triage¿ Drug Screen Controls, when used in accordance with the test procedures || described in the Alere Triage¿ TOX Drug Screen package insert, provide this capability. The results || obtained for the controls are to be compared with the assigned values given on the Expected Values Card, || accompanying the package insert, to determine if the procedure is within control limits. || Alere Triage¿ TOX Drug Screen Control 1 or Alere Triage¿ TOX Drug Screen Control 2 consist of || human urine matrix containing parent compounds and/or major metabolites/analogues of drugs of abuse. || 510(k)/IDE/PMA number: K060788 || Type of Packaging: 5 vials per level in a labeled kit box. || Indications for use: The Alere Triage¿ TOX Drug Screen Controls are to be used with the Alere Triage¿ TOX Drug Screen tests and Alere Triage¿ Meters to assist the laboratory in monitoring test performance.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in vitro diagnostic medical device (IVD).Lot Number 362303ARTG Number: 185171
  • Manufacturer