FDA Product Code
FDA Product Code MRG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1825
510(k) Clearances — 46 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232587 | MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2024-04-12 | Traditional | PDF ↗ |
| K221817 | ALFIS Vitamin D, ALFIS-3 Analyzer | Immunostics Inc., | 2023-09-22 | Traditional | PDF ↗ |
| K223503 | Access 25(OH) Vitamin D Total | Beckman Coulter, Inc. | 2023-01-19 | Traditional | PDF ↗ |
| K210901 | Elecsys Vitamin D total III | Roche Diagnostics | 2021-09-01 | Traditional | PDF ↗ |
| K200509 | ADVIA Centaur Vitamin D Total (VitD) | Siemens Healthcare Diagnostics, Inc. | 2020-05-29 | Traditional | PDF ↗ |
| K191499 | MAGLUMI 2000 25-OH Vitamin D | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2019-08-01 | Traditional | PDF ↗ |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Bio-Rad Laboratories | 2018-06-22 | Traditional | PDF ↗ |
| K172992 | Diazyme EZ Vitamin D Assay | Diazyme Laboratories | 2018-01-11 | Traditional | PDF ↗ |
| K162298 | LOCI Total Vitamin D Total Assay, LOCI VITD CAL | Siemens Healthcare Diagnostics | 2017-03-16 | Traditional | PDF ↗ |
| K162840 | Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 | Roche Diagnostics | 2017-02-08 | Traditional | PDF ↗ |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | 2017-01-12 | Traditional | PDF ↗ |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | 2016-11-15 | Traditional | PDF ↗ |
| K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | Abbott Laboratories | 2016-08-12 | Traditional | PDF ↗ |
| K153361 | Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators | Fujirebio Diagnostics,Inc. | 2016-04-15 | Traditional | PDF ↗ |
| 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 AIA-PACK 25-OH Vitamin D Pretreatment Set | Tosoh Bioscience, Inc. | 2015-10-26 | Traditional | PDF ↗ |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | 2015-08-25 | Traditional | PDF ↗ |
| 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 | 2015-01-09 | Traditional | PDF ↗ |
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst | Beckman Coulter, Inc. | 2014-12-22 | Traditional | PDF ↗ |
| K142362 | Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. | Beckman Coulter, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | Immunodiagnostic Systems , Ltd. | 2014-12-19 | Traditional | PDF ↗ |
| K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | 2014-12-10 | Traditional | PDF ↗ |
| K133156 | ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA | Siemens Healthcare Diagnostics, Inc. | 2014-07-24 | Traditional | PDF ↗ |
| K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET | Diazyme Laboratories | 2014-03-14 | Traditional | PDF ↗ |
| K132492 | LIAISON 25 TOTAL-D | DiaSorin, Inc. | 2013-09-05 | Traditional | PDF ↗ |
| K123660 | 25-OH VITAMIN D ELISA | Euroimmun US | 2013-07-17 | Traditional | PDF ↗ |
| K123364 | 25OH VITAMIN D TOTAL ELISA TEST | Diasource Immunoassays, S.A. | 2013-07-15 | Traditional | PDF ↗ |
| K123983 | FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS | Qualigen, Inc. | 2013-07-03 | Traditional | PDF ↗ |
| 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. | 2013-06-18 | Traditional | PDF ↗ |
| K121608 | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2013-02-15 | Traditional | PDF ↗ |
| 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. | 2013-02-08 | Traditional | PDF ↗ |
| K122420 | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA | Diazyme Laboratories | 2012-11-28 | Traditional | PDF ↗ |
| K113546 | ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 | Roche Diagnostics | 2012-07-24 | Traditional | PDF ↗ |
| K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY | DiaSorin, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K110619 | ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS | Biokit, S.A. | 2011-11-23 | Traditional | PDF ↗ |
| K110586 | ADVIA CENTAUR VITAMIN D TOTAL ASSAY | Siemens Healthcare Diagnostics, Inc. | 2011-10-14 | Traditional | PDF ↗ |
| K102432 | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, | Diazyme Laboratories | 2011-01-14 | Traditional | PDF ↗ |
| K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | Immunodiagnostic Systems, Inc. | 2010-06-25 | Traditional | PDF ↗ |
| K072536 | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST | Esa Biosciences, Inc. | 2008-05-07 | Traditional | PDF ↗ |
| K071480 | LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 | DiaSorin, Inc. | 2007-10-01 | Traditional | PDF ↗ |
| K051110 | 1,25-DIHYDROXY VITAMIN D EIA | Immunodiagnostic Systems , Ltd. | 2005-07-06 | Abbreviated | PDF ↗ |
| K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2004-12-01 | Abbreviated | PDF ↗ |
| K032844 | LIAISON 25 OH VITAMIN D | DiaSorin, Inc. | 2004-02-12 | Traditional | PDF ↗ |
| K021163 | OCTEIA 25-HYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2002-05-10 | Traditional | PDF ↗ |
| K014030 | 1,25-DIHYDROXYVITAMIN D125I RIA | DiaSorin, Inc. | 2002-03-26 | Traditional | PDF ↗ |
| K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | Immunodiagnostic Systems , Ltd. | 1999-09-17 | Traditional | PDF ↗ |
| K953567 | INCSTAR 25-HYDROXYVITMIN D 1251 RIA | Incstar Corp. | 1996-09-25 | Traditional | PDF ↗ |
Product code MRG · Class II · Clinical Chemistry. Data: openFDA.