FDA.reportPublic FDA data

25OH Vitamin D Total

Primary DI
05400569000230
Brand
25OH Vitamin D Total
Company
Diasource Immunoassays S.A. SA
Model
KAP1971
Device description
25OH Vitamin D Total ELISA
Published
2019-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MRGSYSTEM, TEST, VITAMIN D

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRGSystem, Test, Vitamin DClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K12336400025OH VITAMIN D TOTAL ELISA TESTDiasource Immunoassays, S.A.2013-07-15MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05400569000230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05400569000230054005690002305400569000230

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy Vitamin D in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
458777323
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05400569000209IGF-1 ELISAKAP15812020-09-11
05400569000414KIP1131KIP11312020-09-11
05400569000520IGF-1-RIA-CTKIP15882020-09-11
05400569000407hGH-IRMAKIP10812020-01-15
05400569000117INS ELISAKAP12512020-01-10
05400569000087IGFBP-3 ElisaKAP11712020-01-09
05400569000346ANDROSTENEDIONE-RIA-CTKIP04512020-10-05
05400569000452LHsp-IRMAKIP13112020-10-05
05400569000674Estrone-RIA-CTKIPI91002020-09-16
05400569000360E2 RIA CTKIP06292020-09-15
0540056900065011-DESOXYCORTISOL-RIA-CTKIPI200002020-09-15
05400569000049C-PEP-EASIAKPA04012020-09-14
05400569000377FSH IRMAKIP08412020-09-14
05400569000865Androstenedione-ELISAKAPD32652020-09-14
05400569000490PROG-RIA-CTKIP14582020-09-11
05400569001411Trypsin-RIAKIPCE072020-01-29
05400569000322C-PEP II-RIA-CTKIP04092020-01-15
05400569000353DHEA-S-RIA-CTKIP04812020-01-15
05400569000438INS-IRMAKIP1251/KIP12542020-01-15
0540056900047617OHP RIA CTKIP14092020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947145547479MAGLUMI 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.MRG2026-05-15
06947145547486MAGLUMI 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.MRG2026-05-15
06947145547554MAGLUMI 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.MRG2026-05-15
00816870023366Vit D Direct AccuLite CLIA Test System - 96 wellsMONOBIND, INC.MRG2024-09-13
00816870023373Vit D Direct AccuLite CLIA Test System - 192 wellsMONOBIND, INC.MRG2024-09-13
00816870023380Vit D Direct AccuLite CLIA Test System - 480 wellsMONOBIND, INC.MRG2024-09-13
00816870023397Vit D Direct AccuLite CLIA Test System - 960 wellsMONOBIND, INC.MRG2024-09-13
00816870023403Vit D Direct AccuBind ELISA Test System - 96 wellsMONOBIND, INC.MRG2024-09-13
00816870023410Vit D Direct AccuBind ELISA Test System - 192 wellsMONOBIND, INC.MRG2024-09-13
00816870023427Vit D Direct AccuBind ELISA Test System - 480 wellsMONOBIND, INC.MRG2024-09-13
00816870023434Vit D Direct AccuBind ELISA Test System - 960 wellsMONOBIND, INC.MRG2024-09-13
0404847406087425 OH Vitamin D Total (90') ELISADRG Instruments Gesellschaft mit beschränkter HaftungMRG2023-09-01
0084023906087725 OH Vitamin D Total (90') ELISADRG International IncMRG2023-08-26
06947145578053MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.MRG2023-05-17
06947145578060MAGLUMI 2000 25-OH Vitamin DShenzhen New Industries Biomedical Engineering Co., Ltd.MRG2023-05-17
15099590744397Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.MRG2023-02-03
00852169008379ClearChem Diagnostics Inc. Vitamin D (25-OH-D) KitCLEARCHEM DIAGNOSTICS INC.MRG2023-01-20
00852169008386ClearChem Diagnostics Inc. Vitamin D (25-OH-D) SetCLEARCHEM DIAGNOSTICS INC.MRG2023-01-20
07613336172650Elecsys Vitamin D total IIIRoche Diagnostics GmbHMRG2021-12-07
07613336184615Elecsys Vitamin D total IIIRoche Diagnostics GmbHMRG2021-12-07
00630414600321Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.MRG2021-05-28
00630414600338Atellica™ IM VitDSiemens Healthcare Diagnostics Inc.MRG2021-05-28
00630414293837Atellica IM VitDSiemens Healthcare Diagnostics Inc.MRG2020-05-31
05060169695283IDS-iSYS 25 VitDSIMMUNODIAGNOSTIC SYSTEMS LIMITEDMRG2019-09-26
05060169695320IDS-iSYS 25 VitDS Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDMRG2019-09-26
00895160002601Fluoro-CheckTM Vitamin DNANO-DITECH CORPORATIONMRG2019-05-24
00816870020419Monobind AccuBind Vitamin D ELISA Kit - 96 WellsMONOBIND, INC.MRG2019-02-11
00842768037740Dimension® EXL™ Total Vitamin DSiemens Healthcare Diagnostics Inc.MRG2018-12-23
00630414234472Atellica IM VitDSiemens Healthcare Diagnostics Inc.MRG2018-09-29
00630414234489Atellica IM VitDSiemens Healthcare Diagnostics Inc.MRG2018-09-29