FDA.reportPublic FDA data

Dimension® Flex® reagent cartridge DGNA

Primary DI
00842768005503
Brand
Dimension® Flex® reagent cartridge DGNA
Company
Siemens Healthcare Diagnostics Inc.
Model
10444941
Catalog number
DF35A
Device description
Digoxin 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
KXTENZYME IMMUNOASSAY, DIGOXIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXTEnzyme Immunoassay, DigoxinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946153000DIGOXIN FLEX(TM) REAGENT CARTRIDGEE.I. Dupont DE Nemours & Co., Inc.1995-02-22KXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768005503PrimaryGS10
00630414004280Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768005503008427680055038427680055030842768005503
00630414004280006304140042806304140042800630414004280

GMDN Terms#

Term, Definition table
TermDefinition
Digoxin 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 digoxin 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
Primary DIBrandModelCatalogPublished
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
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336121214ONLINE TDM DigoxinRoche Diagnostics GmbHKXT2020-03-05
00380740155988ARCHITECTAbbott GmbHKXT2020-03-03
00380740135324AlinityABBOTT LABORATORIESKXT2018-12-04
00630414598819Atellica IM DigSiemens Healthcare Diagnostics Inc.KXT2018-02-06
00630414598826Atellica IM DigSiemens Healthcare Diagnostics Inc.KXT2018-02-06
00630414595863Atellica CH DgnSiemens Healthcare Diagnostics Inc.KXT2017-12-19
04015630940400Elecsys DigoxinRoche Diagnostics GmbHKXT2017-04-21
04015630995127Tina-quant DigoxinRoche Diagnostics GmbHKXT2016-12-06
00884883011434DRI Digoxin AssayMicrogenics CorporationKXT2016-09-26
05055273206425DGRANDOX LABORATORIES LIMITEDKXT2016-09-24
00842768000966Syva® Emit® 2000 Digoxin AssaySiemens Healthcare Diagnostics Inc.KXT2016-09-24
00842768000973Syva® Emit® 2000 Digoxin CalibratorsSiemens Healthcare Diagnostics Inc.KXT2016-09-24
00842768023255Emit® 2000 Digoxin AssaySiemens Healthcare Diagnostics Inc.KXT2016-09-24
00842768028335Dimension Vista® Flex® reagent cartridge DIGXNSiemens Healthcare Diagnostics Inc.KXT2016-09-24
00630414177410ADVIA Centaur® DIGSiemens Healthcare Diagnostics Inc.KXT2016-09-24
00630414177427ADVIA Centaur® DIG +BSiemens Healthcare Diagnostics Inc.KXT2016-09-24
00630414470375ADVIA® Chemistry DIG Digoxin ReagentsSiemens Healthcare Diagnostics Inc.KXT2016-09-24
00630414961286IMMULITE® 2000 Systems DGX DigoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKXT2016-09-24
00630414963860IMMULITE®/IMMULITE® 1000 Systems DIG DigoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDKXT2016-09-24
04015630911639Elecsys Digoxin AssayRoche Diagnostics GmbHKXT2016-09-20
04015630911646Cobas Elecsys AntiTPORoche Diagnostics GmbHKXT2016-09-20
04015630915682DigoxinRoche Diagnostics GmbHKXT2016-09-20
04015630946761Elecsys Digoxin ImmunoassayRoche Diagnostics GmbHKXT2016-09-20
00884883001206DRI Digoxin AssayMicrogenics CorporationKXT2016-09-12
15099590225766Access Digoxin Calibrator S0Beckman Coulter, Inc.KXT2016-09-09
15099590225780Access Digoxin CalibratorsBeckman Coulter, Inc.KXT2016-09-09
15099590225797Access DigoxinBeckman Coulter, Inc.KXT2016-09-09
15099590232092SynchronBeckman Coulter, Inc.KXT2016-08-24
00380740000240ARCHITECTABBOTT LABORATORIESKXT2016-06-06
00380740001759ARCHITECTABBOTT LABORATORIESKXT2016-06-06