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TPLC
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show TPLC since
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Device
antinuclear antibody, antigen, control
Product Code
LKJ
Regulation Number
866.5100
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
PHADIA AB
SUBSTANTIALLY EQUIVALENT
1
PHADIA US INC.
SUBSTANTIALLY EQUIVALENT
1
1. K082759
ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELI
...
MDR Year
MDR Reports
MDR Events
2017
2
2
2018
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
2
2
Incorrect Or Inadequate Test Results
1
1
Expiration Date Error
1
1
Insufficient Information
1
1
Inadequate Instructions for Healthcare Professional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
2
2
No Information
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Rad Laboratories Inc
II
Mar-02-2011
2
Bio-Rad Laboratories Inc
II
Mar-02-2011
3
Bio-Rad Laboratories Inc
III
Dec-13-2010
4
Bio-Rad Laboratories Inc
II
Dec-13-2010
5
Bio-Rad Laboratories Inc
II
Dec-13-2010
6
Bio-Rad Laboratories Inc
II
Dec-06-2010
7
Bio-Rad Laboratories, Inc.
II
Oct-08-2021
8
Euro Diagnostica AB
III
Oct-11-2018
9
Euro Diagnostica AB
III
Aug-23-2018
10
Euro Diagnostica AB
II
Mar-08-2018
11
Euro Diagnostica AB
II
Dec-20-2017
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