FDA.reportPublic FDA data

Dimension Vista® Flex® reagent cartridge DGTX

Primary DI
00842768033315
Brand
Dimension Vista® Flex® reagent cartridge DGTX
Company
Siemens Healthcare Diagnostics Inc.
Model
10482947
Catalog number
K4036A
Device description
Digitoxin Flex® reagent cartridge, 40 tests
Published
2016-09-24
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
LFMENZYME IMMUNOASSAY, DIGITOXIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFMEnzyme Immunoassay, DigitoxinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062024000DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGEDade Behring, Inc.2006-07-28LFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768033315PrimaryGS10
00630414005775Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768033315008427680333158427680333150842768033315
00630414005775006304140057756304140057750630414005775

GMDN Terms#

Term, Definition table
TermDefinition
Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digitoxin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)441-9250XX@XX.XX
+1(800)441-9250CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
00630414961262IMMULITE 2000 Sytems DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414963846IMMULITE/IMMULITE 1000 DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414598772Atellica IM DgtnSiemens Healthcare Diagnostics Inc.LFM2018-02-06
00630414598789Atellica IM DgtnSiemens Healthcare Diagnostics Inc.LFM2018-02-06
00842768005510Dimension® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414203935ADVIA Centaur® DGTNSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414207414ADVIA Centaur® DGTN +ZSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00884883005648CEDIA Digitoxin AssayMicrogenics CorporationLFM2016-09-12
10758750004782VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LFM2016-08-26