FDA.report

ADVIA Centaur® DHEAS

Primary DI
00630414535333
Brand
ADVIA Centaur® DHEAS
Company
Siemens Healthcare Diagnostics Inc.
Model
10282227
Catalog number
6489701
Device description
DHEA-S - CENTAUR - RGT - 50 tests
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Product Code Classifications

CodeDeviceSpecialtyClass
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00630414535333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414535333006304145353336304145353330630414535333

GMDN Terms

TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
064608573
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00630414287201Atellica HEMA Calibrator11374312113743122026-02-06
00630414289694Atellica HEMA 580 Analyzer (SMS ready)11315457113154572026-02-06
00630414289700Atellica HEMA Slidemaker Stainer (SMS)11315459113154592026-02-06
00630414289953Atellica HEMA Diluent11374303113743032026-02-06
00630414289960Atellica HEMA Diluent11374304113743042026-02-06
00630414312460Atellica HEMA Cleaner11374306113743062026-02-06
00630414312477Atellica HEMA HGB11374307113743072026-02-06
00630414290003Atellica HEMA Baso11374308113743082026-02-06
00630414312484Atellica HEMA RET/PLTO11374309113743092026-02-06
00630414312491Atellica HEMA Diff11374310113743102026-02-06
00630414312507Atellica HEMA Decon11374311113743112026-02-06
00630414323640Atellica HEMA Control (L)11374313113743132026-02-06
00630414323657Atellica HEMA Control (N)11374314113743142026-02-06
00630414323534Atellica HEMA Control (H)11374315113743152026-02-06
00630414323541Atellica HEMA Retic Control (L)11374316113743162026-02-06
00630414323558Atellica HEMA Retic Control (N)11374317113743172026-02-06
00630414323565Atellica HEMA Retic Control (H)11374318113743182026-02-06
00630414323572Atellica HEMA Control BF (N)11374319113743192026-02-06
00630414323589Atellica HEMA Control BF (H)11374320113743202026-02-06
00630414323596Atellica HEMA SMS W-G Stain11559862115598622026-02-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613336232132Ionify Steroids 2Roche Diagnostics GmbHJKC2025-12-11
04049325034754DHEA ELISAIBL International GmbHJKC2025-04-30
00630414632926Atellica IM DHEAS2 100T KITSiemens Healthcare Diagnostics Inc.JKC2025-03-20
00630414321486Atellica IM DHEAS2 (REF) 500TSiemens Healthcare Diagnostics Inc.JKC2025-03-20
04048474015621DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2024-11-22
04048474053463DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474053470DHEA-S DRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474034158DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-29
00840239053466DHEADRG International IncJKC2023-08-26
00840239053473DHEA-S DRG International IncJKC2023-08-26
04048474046526DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-26
00840239034151DHEA ELISADRG International IncJKC2023-08-24
00840239015624DHEA-S ELISADRG International IncJKC2023-08-23
00817830023020MP Biomedicals LLCMp Biomedicals, LLCJKC2023-08-01
15099590211509DHEA-S-7 RIAIMMUNOTECH s.r.o.JKC2023-07-06
04049016140368Dehydroepiandrosterone Sulfate (DHEA-S) ELISAEUROIMMUN Medizinische Labordiagnostika AGJKC2022-12-08
B261CANDH4900DBC Dehydroepiandrosterone (DHEA) ELISADiagnostics Biochem Canada IncJKC2022-11-10
B261CANDHS4800DBC Dehydroepiandrosterone Sulfate (DHEAS) ELISADiagnostics Biochem Canada IncJKC2022-11-10
06925912718550iFlash-DHEA-SShenzhen YHLO Biotech Co., Ltd.JKC2022-10-26
B24211HEAHUE010Dehydroepiandrosterone (DHEA) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
B24220DHSHUE010DHEA-S ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
15099590201432Access DHEA-SBeckman Coulter, Inc.JKC2021-09-23
15099590201449Access DHEA-S CalibratorsBeckman Coulter, Inc.JKC2021-09-23
00404847415629DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847434156DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453461DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453478DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00840239046529DHEA-S ELISADRG International IncJKC2021-06-07
04015630917372Elecsys DHEA-SRoche Diagnostics GmbHJKC2021-01-18
04049325001787DHEA-S ELISAIBL International GmbHJKC2020-12-29