FDA.reportPublic FDA data

Atellica IM Dgtn

Primary DI
00630414598772
Brand
Atellica IM Dgtn
Company
Siemens Healthcare Diagnostics Inc.
Model
10995553
Catalog number
10995553
Device description
Digitoxin (Dgtn) Atellica IM - RGT 250T
Published
2018-02-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFMENZYME IMMUNOASSAY, DIGITOXIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFMEnzyme Immunoassay, DigitoxinClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970546000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970546000ACS DIGITOXINChiron Diagnostics Corp.1997-07-14LFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598772PrimaryGS10
00630414007489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598772006304145987726304145987720630414598772
00630414007489006304140074896304140074890630414007489

GMDN Terms#

Term, Definition table
TermDefinition
Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digitoxin in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414961262IMMULITE 2000 Sytems DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414963846IMMULITE/IMMULITE 1000 DigitoxinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFM2020-08-05
00630414598789Atellica IM DgtnSiemens Healthcare Diagnostics Inc.LFM2018-02-06
00842768005510Dimension® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00842768033315Dimension Vista® Flex® reagent cartridge DGTXSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414203935ADVIA Centaur® DGTNSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00630414207414ADVIA Centaur® DGTN +ZSiemens Healthcare Diagnostics Inc.LFM2016-09-24
00884883005648CEDIA Digitoxin AssayMicrogenics CorporationLFM2016-09-12
10758750004782VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LFM2016-08-26