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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device test, hiv detection
Product CodeMZF
Device Class 3

Device Problems
False Positive Result 671
False Negative Result 86
Incorrect, Inadequate or Imprecise Result or Readings 74
Low Test Results 47
Adverse Event Without Identified Device or Use Problem 37
High Test Results 20
No Apparent Adverse Event 14
Calibration Error 13
Non Reproducible Results 12
Incorrect Or Inadequate Test Results 12
Leak / Splash 3
Improper or Incorrect Procedure or Method 2
Use of Device Problem 2
Failure to Calibrate 1
Chemical Problem 1
Mechanical Problem 1
Human Factors Issue 1
Appropriate Term/Code Not Available 1
Washer 1
Low Readings 1
Total Device Problems 1000


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