FDA.reportPublic FDA data

IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione

Primary DI
00630414963570
Brand
IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10381158
Catalog number
LKAO1
Device description
Androstenedione - IMMULITE - RGT - 100 Tests
Published
2020-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00630414963570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414963570006304149635706304149635700630414963570

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
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
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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