FDA.reportPublic FDA data

Atellica IM CsA PRE Pretreatment

Primary DI
00630414598765
Brand
Atellica IM CsA PRE Pretreatment
Company
Siemens Healthcare Diagnostics Inc.
Model
10995552
Catalog number
10995552
Device description
Cyclosporine (CsA) Pretreatment Atellica IM - CONS (2PK) 2 x 26mL
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKWCYCLOSPORINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKWCyclosporineClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071455000ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATORSiemens Medical Solutions Diagnostics2008-09-11MKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598765PrimaryGS10
00630414007465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598765006304145987656304145987650630414598765
00630414007465006304140074656304140074650630414007465

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect 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
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414482446ADVIA® Chemistry LIP Lipase Reagents10311896103118962020-09-24
00630414510149ADVIA® Chemistry CHE Cholinesterase Reagents10315176103151762020-09-24
00630414526829ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent10335892103358922020-09-24
00630414553191ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated10283347102833472020-09-24
00842768013713Dimension® CTNI Calibrator10444986104449862016-09-24
00842768016936Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge10444901104449012016-09-24
00630414482385ADVIA® Chemistry RF Rheumatoid Factor Reagents10311894103118942016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)10316612103166122016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
00630414947426ADVIA® Chemistry Albumin BCP Calibrator10711842107118422016-09-24
00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents10379635103796352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00869164000079Emit Cyclosporine SampleFUJIREBIO DIAGNOSTICS, INC.MKW2023-12-06
00380740168209Alinity-ArchitectABBOTT LABORATORIESMKW2019-06-14
00630414598727Atellica IM CsASiemens Healthcare Diagnostics Inc.MKW2018-02-06
00630414598741Atellica IM Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2018-02-06
00842768001451Syva® Emit® 2000 Cyclosporine Specific AssaySiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001468Syva® Emit® 2000 Cyclosporine Specific CalibratorsSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001475Syva® Emit® 2000 Cyclosporine Specific Negative CalibratorSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768001482Syva® Emit® Cyclosporine Pretreatment ReagentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768005268Dimension® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768015144Dimension Vista® Flex® reagent cartridge CSASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768016035Dimension Vista® Flex® reagent cartridge CSAESiemens Healthcare Diagnostics Inc.MKW2016-09-24
00842768025136Dimension® CSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00884883011861CEDIA Cyclosporine-PLUS AssayMicrogenics CorporationMKW2016-09-24
00630414524450ADVIA Centaur® CsASiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414524474ADVIA Centaur® CsA PRE PretreatmentSiemens Healthcare Diagnostics Inc.MKW2016-09-24
00630414525549ADVIA Centaur® Multi-Diluent 12Siemens Healthcare Diagnostics Inc.MKW2016-09-24
04015630997459CSAII Cyclosporine IIRoche Diagnostics GmbHMKW2016-09-20
00884883001589CEDIA Cyclosporine PLUS AssayMicrogenics CorporationMKW2016-09-12
00380740081911ARCHITECTABBOTT LABORATORIESMKW2016-09-09
00380740001308ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001315ARCHITECTABBOTT LABORATORIESMKW2016-06-06
00380740001322ARCHITECTABBOTT LABORATORIESMKW2016-06-06