FDA.reportPublic FDA data

Atellica IM VitD DIL

Primary DI
00630414600345
Brand
Atellica IM VitD DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995721
Catalog number
10995721
Device description
Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110586000ADVIA CENTAUR VITAMIN D TOTAL ASSAYSiemens Healthcare Diagnostics, Inc.2011-10-14MRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600345PrimaryGS10
00630414007946Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600345006304146003456304146003450630414600345
00630414007946006304140079466304140079460630414007946

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16

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
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