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U.S. Department of Health and Human Services

Product Classification

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Device ß-glucocerebrosidase (gba) newborn screening test system
Definition For quantitative measurement of the activity of ß-glucocerebrosidase (GBA) from newborn dried blood spot specimens.
Physical State Neonatal screening test
Technical Method Quantitative fluorimetric enzymatic activity assay.
Target Area Newborn dried blood spot specimens.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePQV
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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