Home › Device types › DFH
Kappa, Antigen, Antiserum, Control
FDA product code DFH · Class 2 · Immunology
45
Registered devices
59
Adverse events
2
Recalls
63
510(k) clearances
Devices with this code
N FLC STANDARD SL — Siemens Healthcare Diagnostics Products GmbHIT/IF Control — SEBIAFreelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800 — THE BINDING SITE GROUP LIMITEDDimension Vista® Flex® reagent cartridge LAMBDA — Siemens Healthcare Diagnostics Products GmbHIMMAGE — Beckman Coulter, Inc.Diazyme — DIAZYME LABORATORIES, INC.Freelite® Human Kappa Free Kit for use on the Siemens BN™II — THE BINDING SITE GROUP LIMITEDN FLC CONTROL SL1 — Siemens Healthcare Diagnostics Products GmbHN FLC Standard SL — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Kappa Free Kit for use on the Siemens BN™II - Bulk Kit — THE BINDING SITE GROUP LIMITEDFreelite® Human Kappa Free Kit for use on the Roche Cobas Integra® - Bulk kit — THE BINDING SITE GROUP LIMITEDDiazyme — DIAZYME LABORATORIES, INC.Freelite® Human Kappa Free Kit for use on the Roche cobas® c Systems — THE BINDING SITE GROUP LIMITEDPoly Rb A-Hu Kappa LC — AGILENT TECHNOLOGIES SINGAPORE PTE LTDN FLC Supplementary Reagent — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Kappa Free Kit for use on the SPAPLUS — THE BINDING SITE GROUP LIMITEDN FLC Control SL1 — Siemens Healthcare Diagnostics Products GmbHOptilite Freelite Kappa Kit — THE BINDING SITE GROUP LIMITEDFreelite® Human Kappa Free Kit for use on the Roche Cobas Integra® — THE BINDING SITE GROUP LIMITEDFLC Control Level 2 — SEBIAFreelite® Human Kappa Free Kit for use on the Roche cobas® systems — THE BINDING SITE GROUP LIMITEDFLC Kappa — SEBIAFreelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P — THE BINDING SITE GROUP LIMITEDCAPILLARYS IMMUNOTYPING — SEBIA
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-20 | The Binding Site Group, Ltd. | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| 2020-11-18 | The Binding Site Group, Ltd. | Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned v |
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