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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Specific proteins
Specific proteins
W010201
2,725 devices
Subcategories
5
W01020101
Immunoglobulins (except ige)
570
devices
›
W01020102
Complement components
268
devices
›
W01020103
Transport proteins
501
devices
›
W01020104
Lipoproteins
422
devices
›
W01020190
Other specific proteins
964
devices
›
Devices
Kappa Light Chains (κ-LC) Assay Kit （Immunoturbidimetric Method)
Shenzhen AmTech Bioengineering Ltd., Inc.
·
,
China
IVD General
CE/IVDD
Lambda Light Chain
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Optilite® Freelite Mx™ Kappa Free Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
Kappa Free Light Chains
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
Optilite Freelite Kappa Free Kit
The Binding Site Group Ltd.
·
,
United Kingdom
Class C
FDA 510(k)
×2
K150658
Active
Cleared 26 Aug 2015
CE/IVDR
Omlipo Lambda-FLC Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Nephstar KAP Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Lambda Light Chains (LAM) Detection Kit (Nephelometry)
Genrui Biotech Inc.
·
,
China
IVD General
CE/IVDD
IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent
Beckman Coulter, Inc.
·
,
United States
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
·
,
Italy
IVD General
CE/IVDD
GPP-100 KAP Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Optilite® Freelite® Kappa Free Control Pack
The Binding Site Group Ltd
·
,
United Kingdom
Class C
CE/IVDR
GUDID
on market
Omlipo LAM Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Freelite® Human Lambda Free Kit for use on the Roche cobas® c Systems
The Binding Site Group Ltd
·
,
United Kingdom
Class C
FDA 510(k)
×2
K023131
Active
Cleared 21 Jan 2003
CE/IVDR
+1
authorizations
Omlipo KAP Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Lambda Light Chain (λ-LC) Assay Kit (Immunoturbidimetric Method)
Yhlo Biotech (Nanjing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Omlipo Kappa-FLC Kit
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Optilite® Freelite Mx™ Lambda Free Kit
The Binding Site Group Ltd
·
,
United Kingdom
Class C
FDA 510(k)
K010440
Active
Cleared 26 Apr 2001
CE/IVDR
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