Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
bromcresol green dye-binding, albumin
Product Code
CIX
Regulation Number
862.1035
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
SUBSTANTIALLY EQUIVALENT
1
MEDICON HELLAS, S.A
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1
1
2021
3
3
2022
1
1
2023
5
5
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
9
9
Non Reproducible Results
6
6
Incorrect, Inadequate or Imprecise Result or Readings
4
4
High Test Results
2
2
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics, Inc.
II
Aug-16-2024
2
Roche Diagnostics Operations, Inc.
III
Oct-13-2020
3
Roche Diagnostics Operations, Inc.
III
Oct-16-2019
-
-