FDA.reportPublic FDA data

MAGLUMI 25-OH Vitamin D

Primary DI
06947145547486
Brand
MAGLUMI 25-OH Vitamin D
Company
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Model
130661601M
Catalog number
130661601M
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K232587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232587000MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2024-04-12MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947145547486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947145547486069471455474866947145547486

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
421745241
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947145541781MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer0101010035010101010035012026-05-15
06947145547479MAGLUMI 25-OH Vitamin D130761601M130761601M2026-05-15
06947145547554MAGLUMI 25-OH Vitamin D130261601M130261601M2026-05-15
06947145578039MAGLUMI 2000 HCG/beta-HCG130602022M130602022M2024-05-11
06947145578046MAGLUMI 2000 HCG/beta-HCG130202022M130202022M2024-05-11
06947145578053MAGLUMI 2000 25-OH Vitamin D130211007M130211007M2023-05-17
06947145578060MAGLUMI 2000 25-OH Vitamin D130611007M130611007M2023-05-17
06947145582746Maglumi 2000 Immunoassay Analyzer23020006230200062022-12-31
06947145500016MAGLUMI 2000 TSH130203013M130203013M2022-08-02
06947145500023MAGLUMI 2000 TSH130603013M130603013M2022-08-02
06947145577971MAGLUMI 2000 FT4130603016M130603016M2022-08-02
06947145577988MAGLUMI 2000 FT4130203016M130203016M2022-08-02

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
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
0540056900023025OH Vitamin D TotalDiasource Immunoassays S.A. SAMRG2019-08-21
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