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)
Top companies in CFN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2024 | Beckman Coulter Inc. Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 Open, Classified |
CFN | K073487 |
| Feb 7, 2024 | Siemens Healthcare Diagnostics, Inc. Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry Open, Classified |
CFN | K151767 K992662 |
| Aug 31, 2023 | Beckman Coulter Inc. Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 Open, Classified |
CFN | K073489 |
| Oct 14, 2022 | SIEMENS 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 |
CFN | K083445 |
| Oct 14, 2022 | SIEMENS 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 |
CFN | K083445 |
| Jul 29, 2019 | The Binding Site Group, Ltd. OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 Terminated |
CFN | K191465 K191635 |
| Dec 13, 2018 | The 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 |
CFN | K082129 |
| Nov 17, 2018 | The 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 |
CFN | K082129 |
| Jan 23, 2017 | The 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 |
CFN | K982100 |
| Jan 23, 2017 | The 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 |
CFN | K012295 |
| Jan 23, 2017 | The 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 |
CFN | K012295 |
| Jan 23, 2017 | The 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 |
CFN | K090920 |
| Jan 23, 2017 | The 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 |
CFN | None listed |
| Jan 23, 2017 | The 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 |
CFN | K042152 |
| Jan 23, 2017 | The 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 |
CFN | K042152 |
| Dec 23, 2016 | The Binding Site Group, Ltd. Optilite IgG4 Kit
Product Code: LK009.OPT.A Terminated |
CFN | K150526 |
| Mar 17, 2015 | Siemens 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 |
CFN | K032014 |
| Jan 17, 2007 | Roche Diagnostics Corp. Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic. Terminated |
CFN | K982382 |
| Jul 23, 2004 | Beckman Coulter Inc IMMAGE IGMLC Reagent
Part Number: 447470 Terminated |
CFN | None listed |
| Jul 23, 2004 | Beckman Coulter Inc IMMAGE IGALC Reagent
Part Number: 447460 Terminated |
CFN | K993547 |
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