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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device kit, test, olfactory
Regulation Description Olfactory test device.
Definition The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder.
Product CodeNRK
Regulation Number 874.1600
Device Class 2