ClearanceBrief
Panels › Immunology › Product code CFN · Class 2

Method, Nephelometric, Immunoglobulins (G, A, M)

Regulation 866.5510

0510(k)s in 12 months (61 all time)
0recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in CFN

DateFirm and productCodeLinked 510(k)
Jul 24, 2024Beckman Coulter Inc.
Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
Open, Classified
CFNK073487
Feb 7, 2024Siemens Healthcare Diagnostics, Inc.
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Open, Classified
CFNK151767
K992662
Aug 31, 2023Beckman Coulter Inc.
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Open, Classified
CFNK073489
Oct 14, 2022SIEMENS HEALTHCARE DIAGNOSTICS INC
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Open, Classified
CFNK083445
Oct 14, 2022SIEMENS HEALTHCARE DIAGNOSTICS INC
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
Open, Classified
CFNK083445
Jul 29, 2019The Binding Site Group, Ltd.
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Terminated
CFNK191465
K191635
Dec 13, 2018The Binding Site Group, Ltd.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st
Terminated
CFNK082129
Nov 17, 2018The Binding Site Group, Ltd.
Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st
Terminated
CFNK082129
Jan 23, 2017The Binding Site Group, Ltd.
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of th
Terminated
CFNK982100
Jan 23, 2017The Binding Site Group, Ltd.
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in
Terminated
CFNK012295
Jan 23, 2017The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in s
Terminated
CFNK012295
Jan 23, 2017The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit i
Terminated
CFNK090920
Jan 23, 2017The Binding Site Group, Ltd.
Human lgG4 Subclass Liquid Reagent Kits For use on the Roche Cobas"6000 This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU se
Terminated
CFNNone listed
Jan 23, 2017The Binding Site Group, Ltd.
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaure
Terminated
CFNK042152
Jan 23, 2017The Binding Site Group, Ltd.
Human Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.IM This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckma
Terminated
CFNK042152
Dec 23, 2016The Binding Site Group, Ltd.
Optilite IgG4 Kit Product Code: LK009.OPT.A
Terminated
CFNK150526
Mar 17, 2015Siemens Healthcare Diagnostics, Inc.
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry u
Terminated
CFNK032014
Jan 17, 2007Roche Diagnostics Corp.
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.
Terminated
CFNK982382
Jul 23, 2004Beckman Coulter Inc
IMMAGE IGMLC Reagent Part Number: 447470
Terminated
CFNNone listed
Jul 23, 2004Beckman Coulter Inc
IMMAGE IGALC Reagent Part Number: 447460
Terminated
CFNK993547

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