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U.S. Department of Health and Human Services

Product Classification

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Device material, quality control, semen analysis
Regulation Description Hematology quality control mixture.
Definition A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as ph, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeNRF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 864.8625
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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