FDA.reportPublic FDA data

Elecsys Androstenedione

Primary DI
07613336169308
Brand
Elecsys Androstenedione
Company
Roche Diagnostics GmbH
Model
07679840190
Catalog number
07679840190
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
07613336169308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336169308076133361693087613336169308

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
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
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

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
00630414285566Atellica IM Androstenedione kitSiemens Healthcare Diagnostics Inc.CIZ2019-12-04
00630414603445ADVIA Centaur Androstenedione kitSiemens Healthcare Diagnostics Inc.CIZ2019-10-25