FDA.reportPublic FDA data

Access Digoxin Calibrators

Primary DI
15099590225780
Brand
Access Digoxin Calibrators
Company
Beckman Coulter, Inc.
Model
33715
Catalog number
33715
Device description
The Access Digoxin Calibrators are intended to calibrate the Access Digoxin assay for the Quantitative determination of digoxin levels in human serum
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KXTEnzyme Immunoassay, Digoxin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590225780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022578015099590225780

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16
15099590806439ACCESS anti-HAV QCD258332026-01-16
15099590799717MicroScanV5.03D238242025-12-17
15099590799724MicroScanV5.03D238252025-12-17
15099590799755MicroScanV5.03D238282025-12-17
15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
05099590799017MicroScanD184472025-12-08
05099590799024MicroScanD184482025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336121214ONLINE TDM DigoxinRoche Diagnostics GmbHKXT2020-03-05
00380740155988ARCHITECTAbbott GmbH & Co. KGKXT2020-03-03
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
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
00884883001206DRI Digoxin AssayMicrogenics CorporationKXT2016-09-12
15099590225766Access Digoxin Calibrator S0Beckman 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
00380740001766ARCHITECTABBOTT LABORATORIESKXT2016-06-06