• 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 reagent, borrelia serological reagent
Regulation Description Treponema pallidum treponemal test reagents.
Product CodeLSR
Regulation Number 866.3830
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
EUROIMMUN US
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
GOLD STANDARD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 7
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRINITY BIOTECH
  SUBSTANTIALLY EQUIVALENT 2
VIRAMED BIOTECH AG
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 10 10
2017 9 9
2018 4 4
2019 15 15
2020 7 7
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 30 30
Incorrect, Inadequate or Imprecise Resultor Readings 18 18
Incorrect Or Inadequate Test Results 2 2
Device Operates Differently Than Expected 2 2
Therapeutic or Diagnostic Output Failure 1 1
Unexpected Therapeutic Results 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 11 11
No Patient Involvement 5 5
Misdiagnosis 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Disability 2 2
Confusion/ Disorientation 1 1
No Code Available 1 1
Constipation 1 1
Bacterial Infection 1 1
Diarrhea 1 1
Headache 1 1
Hypoglycemia 1 1
Nausea 1 1
Pain 1 1
Burning Sensation 1 1
Chills 1 1
Ulcer 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Arthritis 1 1
Emotional Changes 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Rash 1 1
Swelling 1 1

-
-