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TPLC
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show TPLC since
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Device
reagent, borrelia serological reagent
Product Code
LSR
Regulation Number
866.3830
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
DIASORIN INC.
SUBSTANTIALLY EQUIVALENT
3
GOLD STANDARD DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
6
ID-FISH TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
VIRAMED BIOTECH AG
SUBSTANTIALLY EQUIVALENT
1
ZEUS SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
ZEUS SCIENTIFIC INC.
SUBSTANTIALLY EQUIVALENT
2
ZEUS SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
7
7
2021
4
4
2022
1
1
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
17
17
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
10
10
No Consequences Or Impact To Patient
8
8
No Clinical Signs, Symptoms or Conditions
6
6
No Patient Involvement
4
4
Disability
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
bioMerieux, Inc.
II
Dec-28-2021
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