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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Specific proteins
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Immunoglobulins (except ige)
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Kappa and lambda chain
Kappa and lambda chain
W0102010109
59 devices
Devices
Nephstar LAM Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Optilite® Freelite Mx™ Lambda Free Control Pack
The Binding Site Group Ltd
·
,
GB
Class C
CE/IVDR
Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems
The Binding Site Group Ltd.
·
,
GB
Class C
CE/IVDR
GUDID
on market
Optilite® Freelite® Lambda Free Kit
The Binding Site Group Ltd
·
,
GB
Class C
CE/IVDR
Kappa Light Chains (κ-LC) Assay Kit （Immunoturbidimetric Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
CN
IVD General
CE/IVDD
Lambda Light Chain
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Optilite® Freelite Mx™ Kappa Free Control Pack
The Binding Site Group Ltd.
·
,
GB
Class C
CE/IVDR
Kappa Free Light Chains
Medicon Hellas SA
·
,
GR
Class B
CE/IVDR
Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems
The Binding Site Group Ltd.
·
,
GB
Class C
CE/IVDR
GUDID
on market
Optilite Freelite Kappa Free Kit
The Binding Site Group Ltd.
·
,
GB
Class C
FDA 510(k)
K150658
Active
Cleared 26 Aug 2015
FDA 510(k)
K010441
Active
Cleared 26 Apr 2001
+1
authorizations
Omlipo Lambda-FLC Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Nephstar KAP Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
Lambda Light Chains (LAM) Detection Kit (Nephelometry)
Genrui Biotech Inc.
·
,
CN
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent
Beckman Coulter, Inc.
·
,
US
IVD General
FDA 510(k)
K964260
Active
Cleared 10 Feb 1997
CE/IVDD
+1
authorizations
Lambda Light Chains (Free+bound)
Ben S.R.L. Biochemical Enterprise
·
,
IT
IVD General
CE/IVDD
GPP-100 KAP Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Optilite® Freelite® Kappa Free Control Pack
The Binding Site Group Ltd.
·
,
GB
Class C
CE/IVDR
GUDID
on market
Omlipo LAM Kit
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems
The Binding Site Group Ltd
·
,
GB
Class C
FDA 510(k)
K023131
Active
Cleared 21 Jan 2003
FDA 510(k)
K140396
Active
Cleared 16 Apr 2014
+2
authorizations
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