FDA.reportPublic FDA data

Atellica IM PSA MCM

Primary DI
00630414599823
Brand
Atellica IM PSA MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10995664
Catalog number
10995664
Device description
Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
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
LTJPROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTJProstate-Specific Antigen (Psa) For Management Of Prostate CancersImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950021015
P950021016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950021015ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG
P950021016ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414599823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414599823006304145998236304145998230630414599823

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Do not freeze, Resuspend.
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
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
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217672Elecsys free PSARoche Diagnostics GmbHLTJ2024-10-24
00630414293738Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00630414294230Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2020-05-31
00816870020594Free fPSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020600Free fPSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020617Total PSA AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020624Total PSA AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870020631Total PSA Extra Sensitive AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870020648Total PSA Extra Sensitive AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022277Free PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022284Monobind AccuLite Free PSA CLIA Kit - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022291Total PSA AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022307Total PSA AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00816870022314Total PSA Extra Sensitive AccuLite CLIA Test System - 96 WellsMONOBIND, INC.LTJ2019-02-11
00816870022321Total PSA Extra Sensitive AccuLite CLIA Test System - 192 WellsMONOBIND, INC.LTJ2019-02-11
00630414599809Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
00630414599816Atellica IM PSASiemens Healthcare Diagnostics Inc.LTJ2018-11-14
08809317540481FREND PSA PlusNanoEnTek, Inc.LTJ2018-05-04
30816467020014FastPack® IP Total PSA Kit (90)QUALIGEN INC.LTJ2017-09-14
08809317540184FREND PSA PlusNanoEnTek, Inc.LTJ2016-09-30
10816467020010FastPack® Total PSA Kit (50)QUALIGEN INC.LTJ2016-09-16
20816467020017FastPack® IP Total PSA Kit (30)QUALIGEN INC.LTJ2016-09-16
10758750000319VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
10758750001309VITROSORTHO CLINICAL DIAGNOSTICSLTJ2016-08-26
00380740008963ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008970ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
14560189212104ST AIA-PACK PATOSOH CORPORATIONLTJ2014-09-24
00630414202952ADVIA Centaur® Systems, ACS 180® Systems PSA MCMSiemens Healthcare Diagnostics Inc.LTJ2014-09-24