• 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 alpha-1-antitrypsin kit, qualitative phenotype
Regulation Description Alpha-1-antitrypsin immunological test system.
Definition The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.
Physical State A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control
Technical Method Isoelectric focusing gel qualitative test.
Target Area Blood serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOBZ
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5130
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