FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740000240
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E06-21
Catalog number
01E0621
Device description
Digoxin
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K023058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023058000QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEMSeradyn2002-10-24KXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740000240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740000240003807400002403807400002400380740000240

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
Handling Environment Temperature029 Degrees Celsius
Special Storage Condition, Specify00Do not freeze reagents or expose reagents to temperatures above 32 Degrees celcius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

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
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
00380740001759ARCHITECTABBOTT LABORATORIESKXT2016-06-06