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
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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