FDA.reportPublic FDA data

AIA-PACK PAP CALIBRATOR SET

Primary DI
04560189211582
Brand
AIA-PACK PAP CALIBRATOR SET
Company
TOSOH CORPORATION
Model
N/A
Published
2016-09-24
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
JFHAcid Phosphatase (Prostatic), Tartrate Inhibited

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFHAcid Phosphatase (Prostatic), Tartrate InhibitedClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211582045601892115824560189211582

GMDN Terms#

Term, Definition table
TermDefinition
Prostatic acid phosphatase (PAP) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of prostatic acid phosphatase (PAP) 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
Premarket exempt
true
Kit
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
14560189210612ST AIA-PACK PAPTOSOH CORPORATIONJFH2016-09-24
04560189211575AIA-PACK PAP SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONJFH2016-09-24
00630414961804IMMULITE® 2000 Systems PAPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJFH2016-09-24
00630414964355IMMULITE®/IMMULITE® 1000 Systems PAPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJFH2016-09-24
00630414996639IMMULITE® Systems PAP CONTROL PAPSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJFH2016-09-24
00811727010001Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDJFH2016-08-31
00811727012210Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDJFH2016-08-31