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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification
Regulation Description Reagents for detection of specific novel influenza A viruses.
Definition 2009 H1N1 influenza virus detection and identification reagents are used to directly detect and differentiate the 2009 H1N1 influenza virus in human respiratory specimens
Product CodeOQW
Regulation Number 866.3332
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 4
Cepheid
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Patient Data Issue 1
Total Device Problems 1

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