FDA.reportPublic FDA data

AU

Primary DI
15099590060183
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR66117
Device description
Calcium Arsenazo
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
CJYAzo Dye, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJYAzo Dye, CalciumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061575000OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117Olympus America, Inc.2006-10-05CJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590060183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959006018315099590060183

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
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
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610230008607Yumizen C1200 Calcium ASHORIBA ABX SASCJY2020-05-06
00380740161491ARCHITECTAbbott GmbHCJY2020-03-09
00380740161507ARCHITECTAbbott GmbHCJY2020-03-09
00380740161514ARCHITECTAbbott GmbHCJY2020-03-09
10758750031795VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJY2019-11-13
05055273208368CALCIUM (Ca)RANDOX LABORATORIES LIMITEDCJY2019-06-03
00386100002060Ca Reagent Kit MEDICA CORPORATIONCJY2019-02-14
00630414220697Atellica CH CA_2Siemens Healthcare Diagnostics Inc.CJY2018-09-24
00380740135409AlinityAbbott GmbHCJY2018-08-31
00380740132613AlinityAbbott GmbHCJY2018-08-08
00817274022450JAS DiagnosticsDREW SCIENTIFIC, INC.CJY2017-04-04
05060500091835Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2017-02-28
00817302023091CAROLINA LIQUID CHEMISTRIES CORP.® CA REAGENT PRODUCT NO. DT251CAROLINA LIQUID CHEMISTRIES CORPORATIONCJY2016-10-17
15099590000325AUBeckman Coulter, Inc.CJY2016-09-24
15099590011086AUBeckman Coulter, Inc.CJY2016-09-24
00857969006105ACEALFA WASSERMANN, INC.CJY2016-09-24
00630414513096ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)Siemens Healthcare Diagnostics Inc.CJY2016-09-24
00630414553160ADVIA® Chemistry CA_2c Calcium_2 Reagents, Concentrated - Arsenazo IIISiemens Healthcare Diagnostics Inc.CJY2016-09-24
EABA40000241Piccolo Basic Metabolic PanelABAXIS, INC.CJY2016-09-23
EABA40000271Piccolo Renal Function PanelABAXIS, INC.CJY2016-09-23
EABA40000281Piccolo Comprehensive Metabolic PanelABAXIS, INC.CJY2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CJY2016-09-23
EABA40000311Piccolo Basic Metabolic Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CJY2016-09-23
EABA40000371Piccolo MetLac 12 PanelABAXIS, INC.CJY2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CJY2016-09-23
00657498000618Calcium (Arsenazo) LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
00657498001462Sirrus® Calcium LiquiColor®STANBIO LABORATORY, L.P.CJY2016-09-23
05060500090463Synermed®INFRARED LABORATORY SYSTEMS LLCCJY2016-09-20