FDA.reportPublic FDA data

Atellica IM cPSA

Primary DI
00630414598680
Brand
Atellica IM cPSA
Company
Siemens Healthcare Diagnostics Inc.
Model
10995544
Catalog number
10995544
Device description
Complexed Prostate Specific Antigen (cPSA) - Atellica IM - RGT - 100T
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
P990055003
P990055004
P990055005
P990055006
P990055007
P990055008
P990055009
P990055010
P990055012
P990055014
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
P990055003BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055004BAYER IMMUNO 1 COMPLEXED PSA ASSAYSiemens Healthcare Diagnostics2000-09-08NAF
P990055005BAYER 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
P990055014BAYER 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
00630414598680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598680006304145986806304145986800630414598680

GMDN Terms#

Term, Definition table
TermDefinition
Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of complexed prostate specific antigen (cPSA) in a clinical specimen, using a chemiluminescent immunoassay method.

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
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
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