FDA.reportPublic FDA data

Alinity

Primary DI
00380740153601
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
01R0921
Catalog number
01R0921
Device description
Alinity c B2-Microglobulin Reagent Kit 200 Tests
Published
2019-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00380740153601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740153601003807401536013807401536010380740153601

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
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
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

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
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