Panels › Clinical Chemistry › Product code MRG · Class 2
System, Test, Vitamin D
Regulation 862.1825
0510(k)s in 12 months (46 all time)
2recalls in 12 months (25 all time)
21recalls that name a 510(k)
Top companies in MRG
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2024 | K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer Shenzhen New Industries Biomedical Engineering Co., Ltd., CN | MRG |
| Sep 22, 2023 | K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer Immunostics Inc., | MRG |
| Jan 19, 2023 | K223503 | Access 25(OH) Vitamin D Total Beckman Coulter, Inc. | MRG |
| Sep 1, 2021 | K210901 | Elecsys Vitamin D total III Roche Diagnostics | MRG |
| May 29, 2020 | K200509 | ADVIA Centaur Vitamin D Total (VitD) Siemens Healthcare Diagnostics, Inc. | MRG |
| Aug 1, 2019 | K191499 | MAGLUMI 2000 25-OH Vitamin D Shenzhen New Industries Biomedical Engineering Co., Ltd., CN | MRG |
| Jun 22, 2018 | K180577 | BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories | MRG |
| Jan 11, 2018 | K172992 | Diazyme EZ Vitamin D Assay Diazyme Laboratories | MRG |
| Mar 16, 2017 | K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL Siemens Healthcare Diagnostics | MRG |
| Feb 8, 2017 | K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics | MRG |
| Jan 12, 2017 | K162754 | FREND Vitamin D Test System Nanoentek USA, Inc. | MRG |
| Nov 15, 2016 | K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems , Ltd., GB | MRG |
| Aug 12, 2016 | K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls Abbott Laboratories | MRG |
| Apr 15, 2016 | K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators Fujirebio Diagnostics,Inc. | MRG |
| Oct 26, 2015 | K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AI Tosoh Bioscience, Inc. | MRG |
| Aug 25, 2015 | K142351 | 25-Hydroxy Vitamin Ds EIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Jan 9, 2015 | K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D Bio-Rad Laboratories | MRG |
| Dec 22, 2014 | K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use Beckman Coulter, Inc. | MRG |
| Dec 19, 2014 | K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use Beckman Coulter, Inc. | MRG |
| Dec 19, 2014 | K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET Immunodiagnostic Systems , Ltd., GB | MRG |
| Dec 10, 2014 | K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS DiaSorin, Inc. | MRG |
| Jul 24, 2014 | K133156 | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA Siemens Healthcare Diagnostics, Inc. | MRG |
| Mar 14, 2014 | K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET Diazyme Laboratories | MRG |
| Sep 5, 2013 | K132492 | LIAISON 25 TOTAL-D DiaSorin, Inc. | MRG |
| Jul 17, 2013 | K123660 | 25-OH VITAMIN D ELISA Euroimmun US | MRG |
| Jul 15, 2013 | K123364 | 25OH VITAMIN D TOTAL ELISA TEST Diasource Immunoassays, S.A. | MRG |
| Jul 3, 2013 | K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS Qualigen, Inc. | MRG |
| Jun 18, 2013 | K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., GB | MRG |
| Feb 15, 2013 | K121608 | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS Ortho-Clinical Diagnostics, Inc. | MRG |
| Feb 8, 2013 | K123131 | ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI Tosoh Bioscience, Inc. | MRG |
| Nov 28, 2012 | K122420 | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA Diazyme Laboratories | MRG |
| Jul 24, 2012 | K113546 | ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 Roche Diagnostics | MRG |
| Jan 20, 2012 | K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY DiaSorin, Inc. | MRG |
| Nov 23, 2011 | K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS Biokit, S.A., ES | MRG |
| Oct 14, 2011 | K110586 | ADVIA CENTAUR VITAMIN D TOTAL ASSAY Siemens Healthcare Diagnostics, Inc. | MRG |
| Jan 14, 2011 | K102432 | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, Diazyme Laboratories | MRG |
| Jun 25, 2010 | K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET Immunodiagnostic Systems, Inc. | MRG |
| May 7, 2008 | K072536 | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST Esa Biosciences, Inc. | MRG |
| Oct 1, 2007 | K071480 | LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 DiaSorin, Inc. | MRG |
| Jul 6, 2005 | K051110 | 1,25-DIHYDROXY VITAMIN D EIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Dec 1, 2004 | K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., GB | MRG |
| Feb 12, 2004 | K032844 | LIAISON 25 OH VITAMIN D DiaSorin, Inc. | MRG |
| May 10, 2002 | K021163 | OCTEIA 25-HYDROXY VITAMIN D Immunodiagnostic Systems , Ltd., GB | MRG |
| Mar 26, 2002 | K014030 | 1,25-DIHYDROXYVITAMIN D125I RIA DiaSorin, Inc. | MRG |
| Sep 17, 1999 | K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA Immunodiagnostic Systems , Ltd., GB | MRG |
| Sep 25, 1996 | K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA Incstar Corp. | MRG |
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