DBF · Ferritin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5340 · Class 2
Overview
| Product Code | DBF |
|---|---|
| Device Name | Ferritin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5340 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | Sep 14, 2021 | SESE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | Mar 6, 2020 | SESE |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | Aug 31, 2017 | SESE |
| K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | Diazyme Laboratories | Jun 24, 2014 | SESE |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | Kamiya Biomedical Company | May 24, 2012 | SESE |
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | Aug 17, 2011 | SESE |
| K100538 | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | Jun 22, 2010 | SESE |
| K092505 | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | Dec 11, 2009 | SESE |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | Nov 20, 2006 | SESE |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | Mar 13, 2006 | SESE |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Good Biotech Corp. | Feb 23, 2006 | SESE |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | Dec 23, 2005 | SESE |
| K040879 | QUANTEX FERRITIN | Instrumentation Laboratory CO | May 10, 2004 | SESE |
| K031650 | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | Jul 17, 2003 | SESE |
| K030124 | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | Feb 6, 2003 | SESE |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | Feb 19, 2002 | SESE |
| K000662 | RANDOX FERRITIN | Randox Laboratories, Ltd. | Apr 3, 2000 | SESE |
| K993273 | N LATEX FERRITIN | Dade Behring, Inc. | Nov 23, 1999 | SESE |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Biocheck, Inc. | Sep 24, 1999 | SESE |
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | Aug 5, 1999 | SESE |
Top Applicants
- Amersham Corp. — 6 clearances
- Hybritech, Inc. — 3 clearances
- Diagnostic Products Corp. — 3 clearances
- Abbott Laboratories — 3 clearances
- Siemens Healthcare Diagnostics, Inc. — 2 clearances
