FDA.reportPublic FDA data

ONLINE TDM Digoxin

Primary DI
07613336121214
Brand
ONLINE TDM Digoxin
Company
Roche Diagnostics GmbH
Model
08057613190
Catalog number
08057613190
Published
2020-03-05
Public version status
New
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
K961824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961824000COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXINRoche Diagnostic Systems, Inc.1996-07-23DCF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121214076133361212147613336121214

GMDN Terms#

Term, Definition table
TermDefinition
Digoxin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetryA 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 nephelometry/turbidimetry method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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