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TPLC
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Device
autoantibodies, endomysial(tissue transglutaminase)
Product Code
MVM
Regulation Number
866.5660
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
1
EUROIMMUN US, INC.
SUBSTANTIALLY EQUIVALENT
1
GRIFOLS USA, INC.
SUBSTANTIALLY EQUIVALENT
1
IMMCO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
INOVA DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
4
1. K094060
QUANTA FLASH H-TTG IGA
2. K101644
QUANTA FLASH H-TTG IGG
3. K193604
Aptiva Celiac Disease IgA Reagent
4. K200230
Aptiva Celiac Disease IgG Reagent
PHADIA AB
SUBSTANTIALLY EQUIVALENT
1
SQI DIAGNOSTICS SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
SQI DIAGNOSTICS SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect Or Inadequate Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Rad Labs
II
Apr-24-2020
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