FDA.reportPublic FDA data

ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y

Primary DI
00630414451114
Brand
ADVIA Centaur® Systems. ACS:180® Systems Calibrator Y
Company
Siemens Healthcare Diagnostics Inc.
Model
10310383
Catalog number
125014
Device description
Calibrator Y - 2 pack (cPSA Cal)
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAFAntigen(Complexed),Prostate Specific,(Cpsa)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAFAntigen(Complexed),Prostate Specific,(Cpsa)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990055001
P990055002
P990055004
P990055006
P990055007
P990055008
P990055009
P990055010
P990055012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990055001BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055002BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055004BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055006BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055007BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055008BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055009BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055010BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055012BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414451114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414451114006304144511146304144511140630414451114

GMDN Terms#

Term, Definition table
TermDefinition
Complexed prostate specific antigen (cPSA) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Lyophilized-until the expiration date on the vial label or reconstituted -21 days or onboard-8hours
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
00630414598680Atellica IM cPSASiemens Healthcare Diagnostics Inc.NAF2018-11-14
00630414598697Atellica IM cPSA MCMSiemens Healthcare Diagnostics Inc.NAF2018-11-14
00630414598703Atellica IM cPSA PRESiemens Healthcare Diagnostics Inc.NAF2018-11-14
00630414598710Atellica IM cPSA QCSiemens Healthcare Diagnostics Inc.NAF2018-11-14
00630414598475Atellica IM Calibrator YSiemens Healthcare Diagnostics Inc.NAF2017-12-22
00630414450872ADVIA Centaur® Systems, ACS 180® Systems cPSA MCMSiemens Healthcare Diagnostics Inc.NAF2014-09-24
00630414450896ADVIA Centaur® cPSASiemens Healthcare Diagnostics Inc.NAF2014-09-24
00630414451558ADVIA Centaur® cPSA PRESiemens Healthcare Diagnostics Inc.NAF2014-09-24
00630414451732ADVIA Centaur® Systems, ACS:180® Systems cPSA 1,2,3 QCSiemens Healthcare Diagnostics Inc.NAF2014-09-24