FDA.reportPublic FDA data

Beckman Coulter Beta-2-Microglobulin Kit

Primary DI
05700572030539
Brand
Beckman Coulter Beta-2-Microglobulin Kit
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
A09445
Device description
Beckman Coulter Beta-2-Microglobulin Kit
Published
2018-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032692000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032692000DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368Dako A/S2004-01-22JZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700572030539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572030539057005720305395700572030539

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572515890Mono Mo A-Hu CD34 Class III/FITC Cl BIRMA-K3F70812020-09-17
05700572005049Mono Mo A-Rb Immunoglobulins Cl MR12/53M07372020-09-17
05700572005339Mono Mo A-Hu Amyloid A Cl mc1M07592020-09-17
05700572006428Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7M70722020-09-17
05700572005100Mono Mo A-Hu CD45R0 Cl UCHL1M07422016-09-16
05700572005599Mono Mo A-Hu Prostatic Acid Phosphatase Cl PASE/4LJM07922020-09-17
05700572006305Mono Mo A-Cytokeratin 17 Cl E3M70462020-09-17
05700572018735Ig Reagent Rb F(ab')2/APCX09982020-09-17
05700572024613Mono Mo A-Hu CD22/APC Cl 4KB128C72812020-09-17
05700572024774Mono Mo a Hu CD61, Platelet Glycoprotein IIIa/APC, Cl Y2/51C72802020-09-17
05700572033929Mono Mo a Hu CD45R0/RPE, Cl UCHL1R08432020-09-17
05700572033936Mono Mo a Hu CD3/PB, Cl UCHT1PB9822020-09-17
05700572033950Mono Mo a Hu CD8/PB, Cl DK25PB9842020-09-17
05700572515258Mono Mo a Hu CD41, Platelet Glycoprotein IIb/RPE, Cl 5B12R70582020-09-17
05700572515432Mono Mo a Hu CD79ß/RPE, Cl SN8R72722020-09-17
05700572515715Mono Mo A-Hu CD7/FITC Cl DK24F07892020-09-17
05700572515746Mono Mo A-Hu CD25, Interleukin-2 Receptor/FITC Cl ACT-1F08012020-09-17
05700572516255Mono Mo a Hu CD5/RPE, Cl DK23R08422020-09-17
05700572516279Mono Mo a Hu CD14/RPE, Cl TÜK4R08642020-09-17
05700572516309Mono Mo a Hu CD16, Fc Gamma Receptor III/RPE, Cl DJ130cR70122020-09-17

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
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