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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kappa, antigen, antiserum, control
Product CodeDFH
Regulation Number 866.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIAZYME LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 3
SEBIA
  SUBSTANTIALLY EQUIVALENT 2
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 6
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 3
  1.  K120056  HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA ...
  2.  K150658  Optilite FreeLite Kappa Free Kit, Optilite Freelit ...
  3.  K173732  Optilite Freelite Mx Kappa Free Kit, Optilite Free ...
THE BINDING SITE LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
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
Adverse Event Without Identified Device or Use Problem 1 1
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 5 5
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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