FDA.reportPublic FDA data

Atellica IM PSA

Primary DI
00630414293738
Brand
Atellica IM PSA
Company
Siemens Healthcare Diagnostics Inc.
Model
11206259
Catalog number
11206259
Device description
Prostate Specific Antigen (PSA) - Atellica IM - RGT - 500T
Published
2020-05-31
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
P950021018

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
P950021018ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAYSiemens Healthcare Diagnostics1995-12-22MTG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293738PrimaryGS10
00630414294230Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293738006304142937386304142937380630414293738
00630414294230006304142942306304142942300630414294230

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
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00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
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00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
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00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217672Elecsys free PSARoche Diagnostics GmbHLTJ2024-10-24
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
00630414599823Atellica IM PSA MCMSiemens 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
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00380740008963ARCHITECTAbbott Ireland DiagnosticsLTJ2014-11-18
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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