FDA.reportPublic FDA data

Atellica IM cPSA PRE

Primary DI
00630414598703
Brand
Atellica IM cPSA PRE
Company
Siemens Healthcare Diagnostics Inc.
Model
10995546
Catalog number
10995546
Device description
Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
Published
2018-11-14
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
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
P990055016
P990055017

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
P990055016BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055017BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598703006304145987036304145987030630414598703

GMDN Terms#

Term, Definition table
TermDefinition
Complexed prostate specific antigen (cPSA) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
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
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
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

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
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
00630414451114ADVIA Centaur® Systems. ACS:180® Systems Calibrator YSiemens 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