FDA.reportPublic FDA data

AU

Primary DI
15099590010126
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6113
Device description
Calcium oCPC
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
CICCresolphthalein Complexone, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CICCresolphthalein Complexone, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924435000OLYMPUS CALCIUM REAGENTOlympus Corp.1992-10-19CIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001012615099590010126

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of calcium (Ca2+) 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
00630414654041Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2026-04-08
00850053916076IDG/SanzayIDG/SANZAY CorporationCIC2024-01-15
10673486001365Teco Diagnostics Calcium Reagent SetTECO DIAGNOSTICSCIC2023-07-25
00811727016065Pointe Calcium ReagentHORIBA INSTRUMENTS INCORPORATEDCIC2021-01-30
00630414550916ADVIA® Chemistry Multi-Drug Urine Controls 1,2Siemens Healthcare Diagnostics Inc.CIC2020-09-24
00811727015754Pointe Calcium Arsenazo for BS480HORIBA INSTRUMENTS INCORPORATEDCIC2020-05-28
00852169008119ClearChem Diagnostics Inc. CalciumCLEARCHEM DIAGNOSTICS INC.CIC2018-04-30
00630414595672Atellica CH CaSiemens Healthcare Diagnostics Inc.CIC2017-12-21
00817274022559JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2017-06-09
00812137011923Calcium Arsenazo III ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIC2016-10-12
00817439020345Calcium / BS480Medtest Dx, Inc.CIC2016-09-27
15099590020057AUBeckman Coulter, Inc.CIC2016-09-24
00842768014123Dimension® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00842768015618Dimension Vista® Flex® reagent cartridge CASiemens Healthcare Diagnostics Inc.CIC2016-09-24
00657498000625Calcium (CPC) LiquiColor®STANBIO LABORATORY, L.P.CIC2016-09-24
00630414508405ADVIA® Chemistry Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414538716ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPCSiemens Healthcare Diagnostics Inc.CIC2016-09-24
00630414555904ADVIA® Chemistry CPC Calcium ReagentsSiemens Healthcare Diagnostics Inc.CIC2016-09-24
04015630901999CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921348CalciumRoche Diagnostics GmbHCIC2016-09-20
04015630921355CalciumRoche Diagnostics GmbHCIC2016-09-20
05060500090432Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090449Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05060500090456Synermed®INFRARED LABORATORY SYSTEMS LLCCIC2016-09-20
05055273200898CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200911CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
05055273200928CaRANDOX LABORATORIES LIMITEDCIC2016-09-16
00817274021088JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021095JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09
00817274021101JAS DiagnosticsDREW SCIENTIFIC, INC.CIC2016-09-09