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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
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New Search show TPLC since Back to Search Results
Device system, test, rheumatoid factor
Regulation Description Rheumatoid factor immunological test system.
Product CodeDHR
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAMIYA BIOMEDICAL CO
  SUBSTANTIALLY EQUIVALENT 1
Kamiya Biomedical Company
  SUBSTANTIALLY EQUIVALENT 1
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE
  SUBSTANTIALLY EQUIVALENT 1
THE BINDING SITE GROUP, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect Or Inadequate Test Results 2
Low Test Results 1
Probe 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 5

Recalls
Manufacturer Recall Class Date Posted
1 Hycor Biomedical Inc II Aug-06-2019
2 Hycor Biomedical Inc II Jul-30-2019
3 Phadia Ab II Jul-01-2019
4 Randox Laboratories Ltd. II Nov-04-2019
5 Stanbio Laboratory, LP II Mar-15-2018
6 The Binding Site Group, Ltd. II May-22-2020
7 The Binding Site Group, Ltd. II Mar-13-2020
8 The Binding Site Group, Ltd. II Feb-08-2018

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