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Dimension® Flex® reagent cartridge DGTX

Primary DI
00842768005510
Brand
Dimension® Flex® reagent cartridge DGTX
Company
Siemens Healthcare Diagnostics Inc.
Model
10444932
Catalog number
DF36
Device description
Digitoxin Flex® reagent cartridge, 80 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
K990251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990251000DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.1999-03-31LFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005510PrimaryGS10
00630414004174Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005510008427680055108427680055100842768005510
00630414004174006304140041746304140041740630414004174

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
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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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
00842768033315Dimension Vista® 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