Product code DBF
- Device name
- Ferritin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5340
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193650 | LIAISON Ferritin | DiaSorin, Inc. | 2021-09-14 |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | HORIBA ABX SAS | 2020-03-06 |
| K171642 | Atellica IM Ferritin Assay | Siemens Healthcare Diagnostics, Inc. | 2017-08-31 |
| K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | Diazyme Laboratories | 2014-06-24 |
| K121232 | K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR | Kamiya Biomedical Company | 2012-05-24 |
| K110736 | ADVIA CHEMISTRY FERRITIN (FRT) METHOD | Siemens Healthcare Diagnostics, Inc. | 2011-08-17 |
| K100538 | TINA-QUANT FERRITIN GEN. 4 | Roche Diagnostics | 2010-06-22 |
| K092505 | BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 | Beckman Coulter, Inc. | 2009-12-11 |
| K062746 | FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 | Medicon Hellas S.A | 2006-11-20 |
| K053211 | RDI HSFERRITIN KIT | Reference Diagnostics, Inc. | 2006-03-13 |
| K052617 | FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, | Good Biotech Corp. | 2006-02-23 |
| K050944 | K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2005-12-23 |
| K040879 | QUANTEX FERRITIN | Instrumentation Laboratory CO | 2004-05-10 |
| K031650 | FERRITIN GENERATION 2 | Roche Diagnostics Corp. | 2003-07-17 |
| K030124 | OLYMPUS FERRITIN REAGENT | Olympus America, Inc. | 2003-02-06 |
| K014293 | K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET | Kamiya Biomedical Co. | 2002-02-19 |
| K000662 | RANDOX FERRITIN | Randox Laboratories, Ltd. | 2000-04-03 |
| K993273 | N LATEX FERRITIN | Dade Behring, Inc. | 1999-11-23 |
| K992517 | BIOCHECK FERRITIN ELISA MODEL BC-1025 | Biocheck, Inc. | 1999-09-24 |
| K992157 | CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY | Chiron Diagnostics Corp. | 1999-08-05 |
| K984186 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAY | Nichols Institute Diagnostics | 1999-02-02 |
| K983340 | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR | Beckman Coulter, Inc. | 1998-12-14 |
| K983759 | ABBOTT ARCHITECT FERRITIN | Abbott Laboratories | 1998-12-07 |
| K982714 | BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY | Bayer Corp. | 1998-10-22 |
| K974505 | AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501 | Alfa Biotech (Uk) , Ltd. | 1998-02-17 |
| K973331 | VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) | Ortho-Clinical Diagnostics, Inc. | 1997-10-22 |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | Behring Diagnostics, Inc. | 1997-09-12 |
| K970612 | SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY | Sealite Sciences, Inc. | 1997-06-24 |
| K963170 | OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-12-02 |
| K951993 | UBI MAGIWEL FERRITIN QUANTITATIVE | United Biotech, Inc. | 1995-07-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414293646 | Atellica IM Fer | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294162 | Atellica IM Fer | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 03610230007327 | Yumizen C1200 Ferritin | HORIBA ABX SAS | 2020-05-06 |
| 07613336121238 | Tina-quant Ferritin Gen.4 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156275 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156329 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00850392007251 | BioCheck Human Ferritin EIA Test Kit | BIOCHECK, INC. | 2019-10-08 |
| 04560189212251 | AIA-PACK FER Calibration Verification Test Set | TOSOH CORPORATION | 2019-07-25 |
| 14560189212258 | AIA-PACK FER Calibration Verification Test Set | TOSOH CORPORATION | 2019-07-25 |
| 08600000686017 | Spectro Ferritin MT | Ramco Laboratories, Inc. | 2019-03-23 |
| 00840239018724 | Ferritin ELISA | DRG International Inc | 2019-03-20 |
| B24225FERHUE010 | Ferritin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-08-03 |
| B1761380 | Antiserum to Human Ferritin | KENT LABORATORIES INC | 2016-09-24 |
| 00842768015182 | Dimension Vista® Flex® reagent cartridge FERR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768008085 | N Latex Ferritin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05055273203097 | FERR | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273203080 | FERR | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273203073 | FERR | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04560189211469 | ST AIA-PACK FER Calibrator Set | TOSOH CORPORATION | 2016-09-24 |
| 04560189211452 | AIA-PACK FER Sample Diluting Solution | TOSOH CORPORATION | 2016-09-24 |
| 15099590011901 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 14560189210483 | ST AIA-PACK FER | TOSOH CORPORATION | 2016-09-24 |
| 04015630922819 | Tinaquant Ferritin Gen4 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630922826 | Tinaquant Ferritin Gen4 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630924431 | Tinaquant Ferritin Gen4 | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630925308 | Tinaquant Ferritin Gen4 | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740030094 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 10758750008506 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 10758750004799 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |
| 15099590223373 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |