FDA.reportPublic FDA data

AIA-PACK BMG Sample Diluting Solution

Primary DI
04560189211179
Brand
AIA-PACK BMG Sample Diluting Solution
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
JZGSystem, Test, Beta-2-Microglobulin Immunological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZGSystem, Test, Beta-2-Microglobulin ImmunologicalImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189211179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189211179045601892111794560189211179

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-microglobulin 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 beta-2-microglobulin 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
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
04048474017892Beta-2 Microglobulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungJZG2023-08-26
06971674866534BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866541BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866558BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866565BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866572BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866589BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866596BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866602BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674866619BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674868019BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
06971674868460BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZG2023-07-22
07613336133583Tinaquant ß2MicroglobulinRoche Diagnostics GmbHJZG2020-03-05
00380740156268ARCHITECTABBOTT LABORATORIESJZG2020-03-03
00380740156312ARCHITECTABBOTT LABORATORIESJZG2020-03-03
00850392007619BioCheck Beta-2 Microglobulin EIA Test KitBIOCHECK, INC.JZG2019-10-08
00840239017895Beta-2 Microglobulin ELISADRG International IncJZG2019-06-10
05055273200775B2Microglobulin (B2M)RANDOX LABORATORIES LIMITEDJZG2019-06-03
05055273208276B2Microglobulin (B2M)RANDOX LABORATORIES LIMITEDJZG2019-06-03
06970291985215β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.JZG2019-03-07
07613336119990Tina-quant ß2-MicroglobulinRoche Diagnostics GmbHJZG2019-02-28
07613336120002Tina-quant ß2-MicroglobulinRoche Diagnostics GmbHJZG2019-02-28
00380740153601AlinityABBOTT LABORATORIESJZG2019-01-04
00816426021280K-ASSAY® Beta-2 Microglobulin ReagentKAMIYA BIOMEDICAL COMPANY, LLCJZG2018-12-19
00816426021297K-ASSAY® Beta-2 Microglobulin Serum / Plasma CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJZG2018-12-19
00816426021303K-ASSAY® Beta-2 Microglobulin Urine CalibratorKAMIYA BIOMEDICAL COMPANY, LLCJZG2018-12-19
05700572030539Beckman Coulter Beta-2-Microglobulin KitAGILENT TECHNOLOGIES SINGAPORE PTE LTDJZG2018-08-08
00630414595566Atellica CH B2MSiemens Healthcare Diagnostics Inc.JZG2017-12-22
B24225BMGHUE010Beta-2 Microglobulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JZG2017-08-03
14560189210261ST AIA-PACK BMGTOSOH CORPORATIONJZG2016-09-24