FDA.reportPublic FDA data

Atellica IM Calibrator Y

Primary DI
00630414598475
Brand
Atellica IM Calibrator Y
Company
Siemens Healthcare Diagnostics Inc.
Model
10995520
Catalog number
10995520
Device description
Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Published
2017-12-22
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

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
00630414598475PrimaryGS10
00630414190914Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598475006304145984756304145984750630414598475
00630414190914006304141909146304141909140630414190914

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
2
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
00630414598710Atellica IM cPSA QCSiemens Healthcare Diagnostics Inc.NAF2018-11-14
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