FDA.reportPublic FDA data

Elecsys Digoxin

Primary DI
04015630940400
Brand
Elecsys Digoxin
Company
Roche Diagnostics GmbH
Model
07027214190
Catalog number
07027214190
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K153301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153301000Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac IIRoche Diagnostics2016-04-08KXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630940400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630940400040156309404004015630940400

GMDN Terms#

Term, Definition table
TermDefinition
Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assayA 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 a chemiluminescent method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

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
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
00842768005503Dimension® Flex® reagent cartridge DGNASiemens 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