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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urine transport kit (excludes hiv testing)
Regulation Description Specimen transport and storage container.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOHZ
Regulation Number 864.3250
Device Class 1

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