FDA.reportPublic FDA data

ADVIA Centaur Androstenedione kit

Primary DI
00630414603445
Brand
ADVIA Centaur Androstenedione kit
Company
Siemens Healthcare Diagnostics Inc.
Model
10997290
Catalog number
10997290
Device description
Androstenedione (Andro) ADVIA Centaur - RGT 50T
Published
2019-10-25
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
00630414603445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414603445006304146034456304146034450630414603445

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

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00840239053398AndrostenedioneDRG International IncCIZ2023-08-26
00840239032652Androstenedione ELISADRG International IncCIZ2023-08-24
05060169691261IDS AndrostenedioneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIZ2023-06-27
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00404847432657Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
00404847450507Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
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05400569000346ANDROSTENEDIONE-RIA-CTDiasource Immunoassays S.A. SACIZ2020-10-05
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00630414961026IMMULITE® 2000 Systems AND AndrostenedioneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCIZ2020-09-24
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