FDA.reportPublic FDA data

ST AIA-PACK PROG II

Primary DI
14560189213392
Brand
ST AIA-PACK PROG II
Company
TOSOH CORPORATION
Model
N/A
Published
2019-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIGSystem, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic CancerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189213392PrimaryGS10
04560189213395Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921339214560189213392
04560189213395045601892133954560189213395

GMDN Terms#

Term, Definition table
TermDefinition
Progesterone IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of progesterone in a clinical specimen, using an enzyme immunoassay (EIA) 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
650-636-8228Ken.Hood@tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14560189212081ST AIA-PACK 27.29N/A2026-02-02
04560189213418ST AIA-PACK PROG II CALIBRATOR SETN/A2026-02-02
04560189210172ST AIA-PACK 27.29N/A2026-02-02
04560189213395ST AIA-PACK PROG II CALIBRATOR SETN/A2019-07-11
14560189210179ST AIA-PACK 27.29N/A2016-09-24
04560189283503G7 Beta-Thalassemia Elution Buffer KitN/A2016-09-24
14560189210339ST AIA-PACK TT3N/A2019-07-25
14560189212135ST AIA-PACK T-UN/A2019-07-25
04560189211742AIA-PACK SUBSTRATE SET IIn/a2019-09-02
04560189212220AIA-PACK C-Peptide Control SetN/A2019-09-02
04560189212749ST AIA-PACK hsE2 CALIBRATOR SETN/A2019-07-24
04560189211759AIA-PACK WASH CONCENTRATEN/A2019-09-02
04560189211766AIA-PACK DILUENT CONCENTRATEN/A2019-09-02
14560189210056AIA-PACK TSH 3rd-GenN/A2016-09-24
14560189210063ST AIA-PACK BetaHCGN/A2016-09-24
14560189210094ST AIA-PACK MyoglobinN/A2016-09-24
14560189210155ST AIA-PACK IgEIIN/A2016-09-24
14560189210230ST AIA-PACK AFPN/A2016-09-24
14560189210261ST AIA-PACK BMGN/A2016-09-24
14560189210315ST AIA-PACK FT4N/A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750034833VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
20758750034830VITROSORTHO CLINICAL DIAGNOSTICSNIG2024-04-25
00630414293516Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2020-05-31
00816870020518CA 19-9 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.NIG2019-02-11
00816870020525CA 19-9 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00816870022192CA 19-9 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.NIG2019-02-11
00816870022208CA 19-9 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.NIG2019-02-11
00380740155919AlinityAbbott GmbHNIG2019-01-03
00630414577135ADVIA Centaur® CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2018-12-01
00630414598161Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2018-02-06
00380740137304ARCHITECTAbbott GmbHNIG2017-12-29
00630414598192Atellica IM CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2017-12-27
00630414598178Atellica IM CA 19-9Siemens Healthcare Diagnostics Inc.NIG2017-12-22
00630414598185Atellica IM CA 19-9 DILSiemens Healthcare Diagnostics Inc.NIG2017-12-22
00380740145392ARCHITECTAbbott GmbHNIG2017-05-01
00380740145408ARCHITECTAbbott GmbHNIG2017-05-01
04015630939640Elecsys CA 19-9Roche Diagnostics GmbHNIG2017-04-14
14560189210209ST AIA-PACK CA 19-9TOSOH CORPORATIONNIG2016-09-24
04560189211124AIA-PACK CA 19-9 Sample Diluting SolutionTOSOH CORPORATIONNIG2016-09-24
00842768028533Dimension Vista® Flex® reagent cartridge CA19-9Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414447926ADVIA Centaur® CA 19-9 MCMSiemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574028ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414574257ADVIA Centaur® CA 19-9™Siemens Healthcare Diagnostics Inc.NIG2016-09-24
00630414577128ADVIA Centaur® CA 19-9™ DILSiemens Healthcare Diagnostics Inc.NIG2016-09-24
04015630904297Elecsys CA 199 ImmunoassayRoche Diagnostics GmbHNIG2016-09-20
15099590231842Access GI MonitorBeckman Coulter, Inc.NIG2016-09-09
10758750002351VITROSORTHO CLINICAL DIAGNOSTICSNIG2016-08-26
00380740003555ARCHITECTABBOTT LABORATORIESNIG2016-06-06
00380740003562ARCHITECTABBOTT LABORATORIESNIG2016-06-06
00380740105464ARCHITECTABBOTT LABORATORIESNIG2016-06-06