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 dna-reagents, neisseria
Regulation Description Neisseria spp. direct serological test reagents.
Product CodeLSL
Regulation Number 866.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 11 11
2023 19 19
2024 17 17
2025 42 42
2026 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 57 57
Erratic Results 21 21
Off-Label Use 16 16
False Negative Result 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Device Markings/Labelling Problem 3 3
Contamination 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Non Reproducible Results 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117
Insufficient Information 3 3
Viral Infection 1 1
Eye Injury 1 1
Sexually Transmitted Infection 1 1
No Consequences Or Impact To Patient 1 1

-
-