Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device positive blood culture processor for inoculum preparation used for antimicrobial susceptibility testing
Definition Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.
Physical State In vitro diagnostic device
Technical Method Processor to prepare an inoculum for subsequent use in antimicrobial susceptibility testing.
Target Area For antimicrobial susceptibility testing using an inoculum of microbial cells recovered from positive blood cultures.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQZX
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-