• 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 ß-galactocerebrosidase (galc) newborn screening test system
Definition For quantitative measurement of the activity of ß-galactocerebrosidase (GALC) from newborn dried blood spot specimens as an aid in screening newborns for Krabbe disease.
Physical State Neonatal screening test, in vitro diagnostic device.
Technical Method Quantitative enzymatic activity assay.
Target Area Newborn dried blood spot specimens.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQCM
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1488
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