• 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 test, barbiturate, over the counter
Definition The barbiturate test is an in vitro diagnostic test for the qualitative analysis of barbiturates in human urine.
Physical State In vitro diagnostic device
Technical Method Immunoassay
Target Area Urine
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodePTH
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons