FDA.reportPublic FDA data

ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION

Primary DI
04560189213371
Brand
ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION
Company
TOSOH CORPORATION
Model
N/A
Published
2019-07-25
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
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14560189213378PackageGS16In Commercial Distribution
04560189213371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1456018921337814560189213378
04560189213371045601892133714560189213371

GMDN Terms#

Term, Definition table
TermDefinition
Sex hormone binding globulin (SHBG) 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 quantitative measurement of sex hormone binding globulin (SHBG) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
650-615-8134Dave.Wurtz@Tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
1
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00894175000763AccuDiag ™Diagnostic Automation, Inc.CDZ2024-01-30
04048474030136Salivary Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474061017Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474046380Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-08-31
00840239030139Salivary Testosterone ELISADRG International IncCDZ2023-08-26
00840239015594Testosterone ELISADRG International IncCDZ2023-08-23
00817830023211MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-03
00817830023204MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-02
15099590211530ACTIVE Free Testosterone RIAIMMUNOTECH s.r.o.CDZ2023-07-06
00894175000817AccuDiag ™Diagnostic Automation, Inc.CDZ2023-07-05
B652IB59109Testosterone (Free) ELISAIBL AmericaCDZ2023-06-08
00850039602726PantexPantexCDZ2023-03-17
00850039602290PantexPantexCDZ2023-02-17
00850039602672PantexPantexCDZ2023-02-17
04987270235393Lumipulse G Testosterone Immunoreaction CartridgesFUJIREBIO INC.CDZ2023-02-01
04049016137740Free Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
04049016140085Total Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
B261CANTE2500DBC Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-15
B261CANFTE2600DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
B261CANFTE260LC80DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
00850039602207Pantex P635STPantexCDZ2022-05-23
00850039602214Pantex P635STPantexCDZ2022-05-23
00850039602221Pantex P635STPantexCDZ2022-05-23
00850039602238Pantex P635STPantexCDZ2022-05-23
00850039602245Pantex P635STPantexCDZ2022-05-23
00850039602252Pantex P635STPantexCDZ2022-05-23