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U.S. Department of Health and Human Services

Product Classification

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Device menopause test system
Definition A menopause test system is an in vitro diagnostic device intended to measure hormones or other analytes in human clinical specimens as an aid in the determination of menopausal status in women.
Physical State In vitro diagnostic device, reagent
Technical Method Immunoassay, other
Target Area Clinical specimens, e.g. blood
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQDH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1093
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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