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TPLC
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Device
system, test, rheumatoid factor
Product Code
DHR
Regulation Number
866.5775
Device Class
2
Premarket Reviews
Manufacturer
Decision
IMMCO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
INOVA DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
KAMIYA BIOMEDICAL COMPANY
SUBSTANTIALLY EQUIVALENT
1
ORGENTEC DIAGNOSTIKA GMBH
SUBSTANTIALLY EQUIVALENT
1
PHADIA AB
SUBSTANTIALLY EQUIVALENT
1
PHADIA US INC.
SUBSTANTIALLY EQUIVALENT
1
SQI DIAGNOSTICS SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE GROUP LTD.
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE GROUP, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Suction Problem
1
1
Low Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2
2
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Oct-01-2012
2
Beckman Coulter Inc.
II
Mar-08-2012
3
Beckman Coulter Inc.
II
Jul-27-2011
4
Beckman Coulter Inc.
II
Mar-22-2011
5
Hycor Biomedical Inc
II
Aug-06-2019
6
Hycor Biomedical Inc
II
Jul-30-2019
7
Ortho-Clinical Diagnostics
II
Jan-11-2012
8
Phadia Ab
II
Jul-01-2019
9
Randox Laboratories Ltd.
II
Nov-04-2019
10
Stanbio Laboratory, LP
II
Mar-15-2018
11
The Binding Site Group, Ltd.
II
May-22-2020
12
The Binding Site Group, Ltd.
II
Mar-13-2020
13
The Binding Site Group, Ltd.
II
Feb-08-2018
14
Thera Test Laboratories, Inc.
II
May-14-2012
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