Home › Device types › DFH
Kappa, Antigen, Antiserum, Control
FDA product code DFH · Class 2 · Immunology
44
Registered devices
55
Adverse events
2
Recalls
63
510(k) clearances
Devices with this code
Antiserum to Human Kappa (free and bound) — KENT LABORATORIES INCFLC Control Level 2 — SEBIAFreelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800 — THE BINDING SITE GROUP LIMITEDN FLC Supplementary Reagent — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Kappa Free Kit for use on the SPAPLUS – 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 LIMITEDOptilite Freelite Kappa Free Bulk Kit — THE BINDING SITE GROUP LIMITEDFreelite® 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 HITACHI 911/912/917/Modular P — THE BINDING SITE GROUP LIMITEDOptilite Freelite Mx Kappa Free Kit — THE BINDING SITE GROUP LIMITEDSheep Anti-Human Kappa Free Light Chains Immunofixation Grade — THE BINDING SITE GROUP LIMITEDN FLC CONTROL SL1 — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Kappa Free Kit for use on the Roche Cobas Integra® — THE BINDING SITE GROUP LIMITEDSPIFE IFE-9 Pentavalent Antisera Kit — HELENA LABORATORIES CORPORATIONFreelite® Human Kappa Free Kit for use on the Roche Cobas Integra® - Bulk kit — THE BINDING SITE GROUP LIMITEDCAPILLARYS IMMUNOTYPING — SEBIAN Antiserum to Human-Ig/L-chain, L-type — Siemens Healthcare Diagnostics Products GmbHN FLC Control SL2 — Siemens Healthcare Diagnostics Products GmbHPoly Rb A-Hu Kappa LC — AGILENT TECHNOLOGIES SINGAPORE PTE LTDIMMAGE — Beckman Coulter, Inc.N FLC Standard SL — Siemens Healthcare Diagnostics Products GmbHFreelite® Human Kappa Free Kit for use on the Roche cobas® systems – Bulk kit — THE BINDING SITE GROUP LIMITEDDiazyme — DIAZYME LABORATORIES, INC.
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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