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TPLC
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show TPLC since
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Device
helicobacter pylori
Product Code
LYR
Regulation Number
866.3110
Device Class
1
Premarket Reviews
Manufacturer
Decision
ALERE SAN DIEGO, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
BIOMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMERIEUX
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
1
DIASORIN, INC.
SUBSTANTIALLY EQUIVALENT
1
GOLD STANDARD DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
MERIDIAN BIOSCIENCE, INC
SUBSTANTIALLY EQUIVALENT
1
MERIDIAN BIOSCIENCE, INC.
SUBSTANTIALLY EQUIVALENT
3
PANION & BF BIOTECH INC.
SUBSTANTIALLY EQUIVALENT
1
TECHLAB, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2015
2
2
2016
4
4
2017
1
1
2020
4
4
2021
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Incorrect Or Inadequate Test Results
5
5
Data Problem
1
1
Appropriate Term/Code Not Available
1
1
False Positive Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7
7
No Patient Involvement
3
3
No Clinical Signs, Symptoms or Conditions
2
2
No Code Available
1
1
No Information
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BioCheck Inc
II
Mar-11-2011
2
Biomerieux Inc
II
Jan-04-2023
3
Calbiotech Inc
II
Mar-05-2010
4
Immunostics, Inc.
II
Jan-10-2024
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