Home › Device types › DCF
Albumin, Antigen, Antiserum, Control
FDA product code DCF · Class 2 · Immunology
42
Registered devices
69
Adverse events
3
Recalls
37
510(k) clearances
Devices with this code
ORTHO — ORTHO-CLINICAL DIAGNOSTICS, INC.AU — Beckman Coulter, Inc.MICROALBUMIN Assay — Sekisui Diagnostics, LLCMicroalbumin ELISA — AMERICAN LABORATORY PRODUCTS COMPANY, LTD.ORTHO — ORTHO-CLINICAL DIAGNOSTICS, INC.CAROLINA LIQUID CHEMISTRIES CORP.® MALB RGT. KIT AU-662 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAtellica CH Urine Albumin (UAlb) — Siemens Healthcare Diagnostics Inc.Microalbumin — Sekisui Diagnostics, LLCSirrus® Albumin LiquiColor® — STANBIO LABORATORY, L.P.IMMAGE — Beckman Coulter, Inc.Antiserum to Human Albumin — KENT LABORATORIES INCTinaquant Albumin Gen2 — Roche Diagnostics GmbHOptilite Albumin Kit — THE BINDING SITE GROUP LIMITEDORTHO — ORTHO-CLINICAL DIAGNOSTICS, INC.DImension Vista® Microalbumin Flex® reagent cartridge — Siemens Healthcare Diagnostics Products GmbHHuman Albumin CSF Kit for use on SPAPLUS — THE BINDING SITE GROUP LIMITEDAlbumin ELISA — Immundiagnostik AGN Antiserum to Human Albumin — Siemens Healthcare Diagnostics Products GmbHSynchron — Beckman Coulter, Inc.K-ASSAY® Microalbumin Reagent — KAMIYA BIOMEDICAL COMPANY, LLCJAS Diagnostics — DREW SCIENTIFIC, INC.Dimension® Flex® reagent cartridge MALB — Siemens Healthcare Diagnostics Inc.ABX PENTRA MICRO ALBUMIN CP — HORIBA ABX SASHuman Albumin NL BINDARID™ Radial Immunodiffusion Kit — THE BINDING SITE GROUP LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-14 | Ortho Clinical Diagnostics Inc | Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored |
| 2017-04-24 | Beckman Coulter Inc. | Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Co |
| 2013-04-30 | Wako Life Sciences, Inc. | Product fails to meet the accuracy at the low end of the measuring range. |
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