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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device kappa, antigen, antiserum, control
Product CodeDFH
Regulation Number 866.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 2
SEBIA
  SUBSTANTIALLY EQUIVALENT 2
  1.  K210623  FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Co ...
  2.  K231601  FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Con ...
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 4
THE BINDING SITE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2021 1 1
2022 11 11
2023 3 3
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 15 15
High Test Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Insufficient Information 2 2
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 The Binding Site Group, Ltd. II Jul-07-2021
2 The Binding Site Group, Ltd. II Feb-01-2021
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