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 muscular dystrophy newborn screening test
Definition A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.
Physical State In vitro neonatal screening kit containing reagents, calibrators and controls
Technical Method Quantitative fluoroimmunoassay
Target Area Newborn dried blood spot specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQJE
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1506
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
-
-