JMG · Radioimmunoassay (Two-Site Solid Phase), Ferritin
Immunology · 21 CFR 866.5340 · Class 2
Overview
| Product Code | JMG |
|---|---|
| Device Name | Radioimmunoassay (Two-Site Solid Phase), Ferritin |
| 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 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K234052 | Access Ferritin | Beckman Coulter, Inc. | Mar 20, 2024 | SESE |
| K052082 | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 | Beckman Coulter, Inc. | Aug 19, 2005 | SESE |
| K964282 | TINA-QUANT FERRITIN ASSAY | Boehringer Mannheim Corp. | Jul 30, 1997 | SESE |
| K971833 | ELECSYS FERRITIN | Boehringer Mannheim Corp. | Jun 2, 1997 | SESE |
| K963498 | FERR FLEX REAGENT CARTRIDGE | Dade Chemistry Systems, Inc. | Jan 24, 1997 | SESE |
| K950393 | ACE(TM) CEDIA(R) FERRITIN ASSAY | Schiapparelli Biosystems, Inc. | May 16, 1995 | SESE |
| K926221 | ACCESS FERRITIN ASSAY | Bio-Rad Laboratories, Inc. | Jan 13, 1993 | SESE |
| K925848 | IMMULITE FERRITIN | Diagnostic Products Corp. | Jan 13, 1993 | SESE |
| K920829 | COBAS CORE FERRITIN EIA | Roche Diagnostic Systems, Inc. | Jun 19, 1992 | SESE |
| K920318 | CEDIA FERRITIN ASSAY | Microgenics Corp. | Jun 4, 1992 | SESE |
| K902997 | MILENIA (TM) FERRITIN | Diagnostic Products Corp. | Aug 2, 1990 | SESE |
| K890697 | RIA-GNOST FERRITIN | Cambridge Medical Technology | Mar 16, 1989 | SESE |
| K881138 | CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. | Baxter Healthcare Corp | Apr 21, 1988 | SESE |
| K873730 | MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Nov 4, 1987 | SESE |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | Aug 21, 1987 | SESE |
| K840460 | CORNINGS MAGIC FERRITIN RADIOIMMUNO- | Corning Medical & Scientific | Mar 30, 1984 | SESE |
| K810799 | QUANTIMUNE FERRITIN IRMA | Bio-Rad | Apr 3, 1981 | SESE |
| K792588 | TERRITIN RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 11, 1980 | SESE |
| K791096 | RADIOIMMUNOASSAY TEST SYSTEM | Corning Medical & Scientific | Aug 3, 1979 | SESE |
| K782157 | IRMA TEST, NORDICLAB FERRITIN | Nordiclab Intl. | Jan 17, 1979 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Beckman Coulter, Inc. — 2 clearances
- Boehringer Mannheim Corp. — 2 clearances
- Corning Medical & Scientific — 2 clearances
- Diagnostic Products Corp. — 2 clearances
