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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neonatal blood collection kit and screening form (excludes hiv testing)
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 CodeOIA
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Disinfection Or Sterilization Issue 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

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