• 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 research use only/hematology devices
Definition For research use only and for products imported into the us only.
Physical State N/A
Technical Method N/A
Target Area N/A
Review Panel Hematology
Product CodeOTQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Third Party Review Not Third Party Eligible
-
-