BEUDAMED
    Product Code: MRG FDA class 2 21 CFR 862.1825

    System, Test, Vitamin D

    Clinical Chemistry

    The Vitamin D Test System is a clinical chemistry in vitro diagnostic device used to measure 25-hydroxyvitamin D levels in patient serum or plasma, enabling assessment of vitamin D status for the diagnosis and monitoring of deficiency or excess. Classified as FDA Class 2 under 21 CFR 862.1825, it requires 510(k) premarket notification. The product code is MRG, and it is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    46
    FEI Numbers
    51
    Registration Numbers
    51
    Unique Applicants
    22
    Years Active
    28

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    Basic Information

    Product Code
    MRG
    Device Class
    FDA class 2
    Regulation Number
    862.1825
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 46 510(k) clearances via K numbers.

    K Number Device Name
    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
    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.
    K140554 IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
    K141463 LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
    K133156 ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY;ADVIA CENTAUR VITD TOTAL CALIBRATORS,QUALITY CONTROL & MASTER CONTROL MATERIA
    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

    FEI Numbers

    This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.