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U.S. Department of Health and Human Services

Product Classification
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Device menstrual blood collection device
Regulation Description Blood specimen collection device.
Definition Intended to collect and transport menstrual blood specimens to the laboratory for in vitro diagnostic testing
Physical State A menstrual blood collection device that may include blood collection paper
Technical Method The menstrual blood is absorbed or drawn into the collection device for transport or storage
Target Area Collects menstrual blood for in vitro diagnostic testing
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeQZG
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1675
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
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