FDA.reportPublic FDA data

Atellica IM PSA

Primary DI
00630414294230
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950021015ADVIA 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

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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
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00630414947419ADVIA® Chemistry Albumin BCP Reagents10711841107118412016-09-24
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00630414465401ADVIA® Chemistry CHE Cholinesterase Reagents10329639103296392020-09-24
00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
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
00630414293738Atellica 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
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