FDA.reportPublic FDA data

Atellica IM Androstenedione kit

Primary DI
00630414285566
Brand
Atellica IM Androstenedione kit
Company
Siemens Healthcare Diagnostics Inc.
Model
11200558
Catalog number
11200558
Device description
Androstenedione (Andro) Atellica IM - RGT 50T
Published
2019-12-04
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
CIZRADIOIMMUNOASSAY, ANDROSTENEDIONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIZRadioimmunoassay, AndrostenedioneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414285566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414285566006304142855666304142855660630414285566

GMDN Terms#

Term, Definition table
TermDefinition
Androstenedione IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione 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, Do Not Freeze, Resuspend
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
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414580722ADVIA Centaur® aTG MCM10492692104926922016-09-24
00630414602875VERSANT HCV 2.0 LiPA10492004104920042017-09-15
00630414602882VERSANT HCV 2.0 LiPA10492005104920052017-09-15
00630414008950ADVIA Chemistry P5PL_c Reagent10729782107297822021-11-04
00630414508368ADVIA® Chemistry ALT(GPT) Reagents10309500103095002020-09-24
00630414513157ADVIA® Chemistry IRON_2 Reagents10341118103411182020-09-24
00630414553139ADVIA® Chemistry ALT_c, ALT (GPT) Reagents, Concentrated10283341102833412020-09-24
00630414002873ADVIA Chemistry Enzymatic hemoglobin A1c Calibrator10720859107208592018-07-06
00630414224923ADVIA Cystatin C_2 Calibrator10734510107345102018-09-24
00630414517445ADVIA® Chemistry Lactate Dehydrogenase P-L (LDPL) Reagents10341129103411292016-09-24
00842768004872Dimension® TACR Calibrator10445012104450122016-09-24
00842768018312Dimension® Flex® reagent cartridge TACR10444938104449382016-09-24
00630414000497VERSANT HCV 2.0 LiPA10719666107196662017-09-15
00630414000503VERSANT HCV 2.0 LiPA10719667107196672017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000824AccuDiag™ ANST (Androstenedione) ELISADiagnostic Automation, Inc.CIZ2026-01-27
00816870023816ANST AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CIZ2024-09-13
00816870023823ANST AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CIZ2024-09-13
00816870024707ANST AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CIZ2024-09-13
00816870024714ANST AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CIZ2024-09-13
04048474053395Androstenedione DRG Instruments Gesellschaft mit beschränkter HaftungCIZ2023-09-01
04048474032659Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2023-08-29
00840239053398AndrostenedioneDRG International IncCIZ2023-08-26
00840239032652Androstenedione ELISADRG International IncCIZ2023-08-24
05060169691261IDS AndrostenedioneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIZ2023-06-27
04049016138365Androstenedione ELISAEUROIMMUN Medizinische Labordiagnostika AGCIZ2022-12-08
B261CANAD2080DBC Androstenedione ELISADiagnostics Biochem Canada IncCIZ2022-11-15
06925912718055iFlash-AndrostenedioneShenzhen YHLO Biotech Co., Ltd.CIZ2022-10-26
00404847432657Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
00404847450507Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
00404847453393AndrostenedioneDRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
05400569000346ANDROSTENEDIONE-RIA-CTDiasource Immunoassays S.A. SACIZ2020-10-05
B24211ANRHUE010Androstenedione ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CIZ2020-09-25
00630414961026IMMULITE® 2000 Systems AND AndrostenedioneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCIZ2020-09-24
00630414963570IMMULITE®/IMMULITE® 1000 Systems AND AndrostenedioneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCIZ2020-09-24
05400569000865Androstenedione-ELISADiasource Immunoassays S.A. SACIZ2020-09-14
07613336169292Elecsys AndrostenedioneRoche Diagnostics GmbHCIZ2020-03-05
07613336169308Elecsys AndrostenedioneRoche Diagnostics GmbHCIZ2020-03-05
00630414603445ADVIA Centaur Androstenedione kitSiemens Healthcare Diagnostics Inc.CIZ2019-10-25