FDA.reportPublic FDA data

AU

Primary DI
15099590010850
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6189
Device description
Magnesium
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JGJPhotometric Method, Magnesium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGJPhotometric Method, MagnesiumClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K944407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944407000OLYMPUS MAGNESIUM REAGENTOlympus America, Inc.1994-12-27JGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001085015099590010850

GMDN Terms#

Term, Definition table
TermDefinition
Magnesium (Mg2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486002096Teco Diagnostics Magnesium Reagent SetTECO DIAGNOSTICSJGJ2023-11-14
10673486002126Teco Diagnostics Magnesium Reagent Kit for TC-Matrix TECO DIAGNOSTICSJGJ2023-11-14
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024289CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT CC220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024449CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT DT220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024586CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT ST220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00380740169855ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740169862ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740176525AlinityABBOTT IRELANDJGJ2021-12-27
00380740176532AlinityABBOTT IRELANDJGJ2021-12-27
04015630913381MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630926992MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630930821Magnesium Gen.2Roche Diagnostics GmbHJGJ2021-02-08
00811727015938Pointe Magnesium ReagentHORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00811727016232Pointe Magnesium Reagent HORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00630414595597Atellica CH MgSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768014185Dimension® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768015694Dimension Vista® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
03610230007112Yumizen C1200 MagnesiumHORIBA ABX SASJGJ2020-08-28
10758750000265VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
10758750004621VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
07613336121412Magnesium Gen.2Roche Diagnostics GmbHJGJ2020-03-05
07613336169438Magnesium Gen.2Roche Diagnostics GmbHJGJ2019-07-01
05055273204629MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
05055273209303MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
00386100002169Mg Reagent KitMEDICA CORPORATIONJGJ2019-02-14
00380740121839AlinityAbbott GmbHJGJ2019-02-12
00380740121846AlinityAbbott GmbHJGJ2019-02-12
00380740161620ARCHITECTAbbott GmbHJGJ2019-02-05