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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device urine collection kit (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 CodeOIE
Regulation Number 864.3250
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2017 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination With Biological Material 1 1
Device Markings/Labelling Problem 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 2 2
Needle Stick/Puncture 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Gen-Probe Inc III Jun-14-2014
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