FDA.reportPublic FDA data

Atellica IM cPSA QC

Primary DI
00630414598710
Brand
Atellica IM cPSA QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995547
Catalog number
10995547
Device description
Complexed Prostate Specific Antigen (cPSA) QC Kit - Atellica IM - CLT 3 x 1 x 2.0mL
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
P990055007
P990055008
P990055012
P990055016
P990055017

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990055001BAYER 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
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
00630414598710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598710006304145987106304145987100630414598710

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
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

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
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