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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vacuum powered body fluid collection kit
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 CodeOJR
Regulation Number 878.4780
Device Class 2

MDR Year MDR Reports MDR Events
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Erratic Results 9 9
No Apparent Adverse Event 7 7
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17

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