FDA.reportPublic FDA data

Alinity

Primary DI
00380740158316
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
07P9221
Catalog number
07P9221
Device description
Alinity i Total PSA Reagent Kit 200 Tests
Published
2020-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTFTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740158316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740158316003807401583163807401583160380740158316

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
985307301
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590701673Access Hybritech PSABeckman Coulter, Inc.MTF2025-05-30
07613336217665Elecsys Total PSARoche Diagnostics GmbHMTF2024-10-24
00380740130411AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740130428AlinityAbbott Ireland DiagnosticsMTF2020-11-18
00380740158323AlinityAbbott Ireland DiagnosticsMTF2020-11-18
07613336165980Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336165997Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336166000Elecsys total PSARoche Diagnostics GmbHMTF2020-08-24
07613336167496total PSA CalSet IIRoche Diagnostics GmbHMTF2020-08-24
04015630939824Elecsys total PSARoche Diagnostics GmbHMTF2018-07-16
00630414598444Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-27
00630414598451Atellica IM Calibrator QSiemens Healthcare Diagnostics Inc.MTF2017-12-22
07613336154366Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
07613336154373Elecsys tPSARoche Diagnostics GmbHMTF2017-09-29
07613336154380total PSA Calset IIRoche Diagnostics GmbHMTF2017-09-29
04015630920754Elecsys Total PSA CalSet IIRoche Diagnostics GmbHMTF2014-12-18
00380740008963ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008970ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008987ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00380740008994ARCHITECTAbbott Ireland DiagnosticsMTF2014-11-18
00842768013874Dimension® clinical chemistry system TPSA Flex® reagent cartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00842768016660Dimension Vista® System TPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202921ADVIA Centaur® Systems, ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414202938ADVIA Centaur® Systems. ACS:180® Systems Calibrator QSiemens Healthcare Diagnostics Inc.MTF2014-09-24
00630414954196IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982205IMMULITE®/IMMULITE®1000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982212IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982229IMMULITE® 2000 Systems PTS PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982267IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24
00630414982281IMMULITE®Systems sPS CONTROL Third Generation PSASIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMTF2014-09-24