FDA.reportPublic FDA data

Fluoro-CheckTM Vitamin D

Primary DI
00895160002601
Brand
Fluoro-CheckTM Vitamin D
Company
NANO-DITECH CORPORATION
Model
TF8148
Catalog number
TF8148
Device description
An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen.
Published
2019-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRGSystem, Test, Vitamin D

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00895160002601PrimaryGS10
10895160002608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00895160002601008951600026018951600026010895160002601
1089516000260810895160002608

GMDN Terms#

Term, Definition table
TermDefinition
Multiple form 25-hydroxy vitamin D IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen within a short period, relative to standard laboratory testing procedures using an immunochromatographic method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-297-7877info@nanoditech.com
1-609-409-3300info@nanoditech.com

Regulatory Flags#

DUNS number
126544316
Device count
20
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00895160002427Fluoro-CheckTM PCTTF3161TF31612016-10-05
00895160002878Nano-Check™ Influenza A+B TestMD81532026-01-22
10895160002875Nano-Check™ Influenza A+B TestMD81532026-01-22
00895160002960Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
10895160002967Nano-Check Influenza+COVID-19 Dual TestMD81542026-01-16
00895160002847Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
10895160002844Nano-Check Influenza+COVID-19 Dual TestMD8151E2024-08-08
00895160002854Nano-Check RSV TestMD81522024-08-08
00895160002861Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
10895160002868Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147 2T2024-04-01
00895160002786Nano-Check TM COVID-19 Antigen TestMD-8147MD-8147-20T2020-11-18
00895160002243Nano-Check™ OPI TestAD41832023-06-27
10895160002240Nano-Check™ OPI TestAD41832023-06-27
00895160002663Nano-CheckTM COVID-19 IgG/IgM Antibody TestMD81452020-04-10
00895160002670Fluoro-CheckTM CRP Test TF31632020-09-22
00895160002687Nano-Check TM Strep A TestMD81482022-03-15
00895160002694Nano-Check TM CRP plus TestCD71572022-03-15
00895160002724Nano-Check TM COVID-19 IgG Antibody TestMD81462020-09-22
00895160002793Fluoro-Check TM COVID-19 Antigen TestTF-81502020-11-25
00895160002120Nano-CheckTM AMI 2 in 1CD202PCD202P2016-09-14

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