• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device bromcresol green dye-binding, albumin
Regulation Description Albumin test system.
Product CodeCIX
Regulation Number 862.1035
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSYSTEMS S.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 6 6
2018 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 7 7
Adverse Event Without Identified Device or Use Problem 2 2
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. III Oct-13-2020
2 Roche Diagnostics Operations, Inc. III Oct-16-2019
-
-