• 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 system, test, c-reactive protein
Regulation Description C-reactive protein immunological test system.
Product CodeDCN
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2018 2 2
2019 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 9 9
Low Test Results 2 2
Non Reproducible Results 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Mar-31-2020
2 The Binding Site Group, Ltd. II Dec-12-2019
-
-