Product code MRG— Clinical Chemistry
1,25-DIHYDROXY VITAMIN D EIA
- Classification name
- System, Test, Vitamin D
- Device class
- Class 2
- Regulation
- 21 CFR 862.1825
- Advisory panel
- Clinical Chemistry
- Total cleared
- 46
- First cleared
- Most recent
Market context for product code MRG
FDA has cleared devices under product code MRG between 1996 and 2024, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2008
Top applicants under product code MRG
Recent clearances under product code MRG
- K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
- K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer
- K223503 — Access 25(OH) Vitamin D Total
- K210901 — Elecsys Vitamin D total III
- K200509 — ADVIA Centaur Vitamin D Total (VitD)
- K191499 — MAGLUMI 2000 25-OH Vitamin D
- K180577 — BioPlex 2200 25-OH Vitamin D Kit
- K172992 — Diazyme EZ Vitamin D Assay
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K162840 — Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
- K162754 — FREND Vitamin D Test System
- K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
- K153375 — ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
- K153361 — Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
- 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
- K142351 — 25-Hydroxy Vitamin Ds EIA
- 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
- 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
- K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
- 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.
- K141463 — LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
- K133156 — ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY +1 more
- K133410 — DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET
- K132492 — LIAISON 25 TOTAL-D
- K123660 — 25-OH VITAMIN D ELISA
- K123364 — 25OH VITAMIN D TOTAL ELISA TEST
- K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
- 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
- K121608 — VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
- 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
- K122420 — DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
- K113546 — ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
- K112725 — LIAISON 25 OH VITAMIN D TOTAL ASSAY
- K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
- K110586 — ADVIA CENTAUR VITAMIN D TOTAL ASSAY
- K102432 — DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
- K091849 — IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
- K072536 — ESA BIOSCIENCES INC. VITAMIN D HPLC TEST
- K071480 — LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602
- K051110 — 1,25-DIHYDROXY VITAMIN D EIA
- K042519 — GAMMA-B 1,25-DIHYDROXY VITAMIN D
- K032844 — LIAISON 25 OH VITAMIN D
- K021163 — OCTEIA 25-HYDROXY VITAMIN D
- K014030 — 1,25-DIHYDROXYVITAMIN D125I RIA
- K991998 — GAMMA-B 25-HYDROXY VITAMIN D RIA
- K953567 — INCSTAR 25-HYDROXYVITMIN D 1251 RIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.