FDA.reportPublic FDA data

AIA-PACK PA SAMPLE DILUTING SOLUTION

Primary DI
04560189211995
Brand
AIA-PACK PA SAMPLE DILUTING SOLUTION
Company
TOSOH CORPORATION
Model
n/a
Published
2014-09-24
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
MVUReagents,Specific,Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211995045601892119954560189211995

GMDN Terms#

Term, Definition table
TermDefinition
Total prostate specific antigen (tPSA) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@Tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
1
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
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
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00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22