FDA.reportPublic FDA data

β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)

Primary DI
06970291985215
Brand
β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)
Company
Medicalsystem Biotechnology Co., Ltd.
Model
None
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06970291985215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970291985215069702919852156970291985215

GMDN Terms#

Term, Definition table
TermDefinition
Beta-2-microglobulin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-2-microglobulin in a clinical specimen, using a nephelometry/turbidimetry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545261989
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970291985222Microalbuminuria Kit (Immunoturbidimetric Method)None2019-03-07
06970291985185Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)None2019-03-07
06970291985154Aspartate Aminotransferase Kit (Colorimetric Method )None2019-03-07
06970291985178Lactate Dehydrogenase Kit (Kinetic Method)None2019-03-07
06970291985161Haptoglobin Kit (Immunoturbidimetric Method)None2019-03-07
06970291985192Total Protein Kit (Biuret Method)None2019-03-07
06970291985208Total Protein Kit (Biuret Method) (2-Part Reagents)None2019-03-07

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
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
15099590010485AUBeckman Coulter, Inc.JZG2016-09-24