Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
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 nucleic-acid tests used for infectious disease screening of blood and plasma donations
Regulation Description Test requirements.
Definition For the qualitative detection of nucleic acid for infectious disease agents in human specimens.
Product CodeQHO
Regulation Number 610.40
Device Class Unclassified

MDR Year MDR Reports MDR Events
2021 14 14
2022 10 10
2023 12 12
2024 11 11
2025 351 351
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 208 208
Output Problem 184 184
Non Reproducible Results 129 129
False Positive Result 128 128
False Negative Result 124 124
Incorrect Measurement 4 4
Unable to Obtain Readings 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 385 385
Insufficient Information 16 16
Hepatitis 4 4
No Consequences Or Impact To Patient 1 1

-
-