FDA.reportPublic FDA data

IDS Androstenedione

Primary DI
05060169691261
Brand
IDS Androstenedione
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-5400
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
05060169691261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169691261050601696912615060169691261

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store in an upright position
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660techsupport.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27
05060169690141Urine CrossLaps® (CTX-I) EIAAC-03F12023-06-23

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