FDA.reportPublic FDA data

ADVIA Centaur® H2n

Primary DI
00630414471235
Brand
ADVIA Centaur® H2n
Company
Siemens Healthcare Diagnostics Inc.
Model
10308994
Catalog number
915031
Device description
HER-2/neu - CENTAUR - RGT - 50 tests
Published
2016-09-24
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
NCWSYSTEM, TEST, HER-2/NEU, MONITORING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NCWSystem, Test, Her-2/Neu, MonitoringImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024017000BAYER ADVIA CENTAUR HER-2/NEU ASSAYBayer Corp.2003-01-30NCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414471235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414471235006304144712356304144712350630414471235

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase Reagents1031517814108202016-09-24
00630414595641Atellica CH PAmy11097622110976222017-12-21
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414599151Atellica IM H2nSiemens Healthcare Diagnostics Inc.NCW2018-02-06
00630414599168Atellica IM H2n CalibratorSiemens Healthcare Diagnostics Inc.NCW2018-02-06
00630414599175Atellica IM H2n MCMSiemens Healthcare Diagnostics Inc.NCW2018-02-06
00630414599182Atellica IM H2n QCSiemens Healthcare Diagnostics Inc.NCW2018-02-06
00630414469850ADVIA Centaur® H2n MCMSiemens Healthcare Diagnostics Inc.NCW2016-09-24
00630414471211ADVIA Centaur® H2n QCSiemens Healthcare Diagnostics Inc.NCW2016-09-24
00630414471228ADVIA Centaur® H2n CalibratorSiemens Healthcare Diagnostics Inc.NCW2016-09-24