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  • Package Insert - MRESVIA - U. S. Food and Drug Administration
    Package Insert - MRESVIA - U S Food and Drug Administration
  • CLIA - Clinical Laboratory Improvement Amendments - Currently Waived . . .
    The following is a list of analytes that are used in laboratory test systems that have been "waived" Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver
  • Public Databases | FDA - U. S. Food and Drug Administration
    Clinical Laboratory Improvement Amendments - Currently Waived Analytes provides a listing of all tests that are currently categorized as waived for any reason (i e , by regulation, by marketing
  • CLIA Waiver by Application Approval Determination
    The operating principles of the Xpert Xpress Flu RSV Assa, Xpert Xpress Flu Assay, GeneXpert Xpress System and Assay Definition Files (ADF) remain unchanged 2 Test System Components The assay kit contains the following test components: • Xpert Xpress Flu RSV or Xpert Xpress Flu Test Cartridges with Integrated Reaction Tubes (10 or 120 per kit)
  • CLIA Waiver by Application Decision Summaries | FDA
    Tests that are waived by regulation under 42 CFR 493 15(c), or cleared or approved for home use or for over-the-counter use, are automatically categorized as waived following clearance or approval
  • CLIA Categorizations - FDA
    For CLIA categorization purposes, a test system commonly includes both an instrument analyzer and an assay, but may be a unitized device (e g , a manually read lateral flow test), a manual assay
  • MRESVIA | FDA - U. S. Food and Drug Administration
    Active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older Product Information
  • FDA Label Search
    IMPORTANT DISCLAIMER Please be aware of the following when using information from this Web site: The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA)
  • CLIA Waiver by Application Approval Determination - Food and Drug . . .
    The device contains all of the hardware and reagents required to perform the test Each kit contains 10 test devices, 12 single use disposable fixed-volume transfer pipettes and 12 biohazard bags The unit is outlet powered with a reusable power adaptor that is packaged separately
  • CLIA Waiver by Application Approval Determination
    I Test System Description 1 Overview The Xpert HCV test, is an automated qualitative in vitro reverse transcription polymerase chain reaction (RT-PCR) test The Xpert HCV test is performed on the GeneXpert Xpress System With this system an operator can run the test by performing four simple steps: 1) mix the specimen, 2)





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