FDA.reportPublic FDA data

AU

Primary DI
15099590010102
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6111
Device description
Direct Bilirubin
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
CIGDiazo Colorimetry, Bilirubin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924963000OLYMPUS DIRECT BILIRUBIN REAGENTOlympus Corp.1992-11-30CIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001010215099590010102

GMDN Terms#

Term, Definition table
TermDefinition
Conjugated (direct) bilirubin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of conjugated (direct) bilirubin 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
07613336235508Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-02-04
07613336235515Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
07613336235522Bilirubin Total Gen.3Roche Diagnostics GmbHCIG2025-01-31
00630414614755Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414614922Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313429Atellica CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00630414313436Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics Inc.CIG2024-10-16
00380740167561ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167578ARCHITECTABBOTT IRELANDCIG2024-08-15
00380740167585AlinityABBOTT IRELANDCIG2024-08-15
00850053916045IDG/SanzayIDG/SANZAY CorporationCIG2024-01-08
04015630924912Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
04015630927531Bilirubin Direct Gen.2 (Doumas standardization)Roche Diagnostics GmbHCIG2023-10-06
10673486001204Teco Diagnostics Direct Bilirubin TC-MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001211Teco Diagnostics Direct Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001280Teco Diagnostics Total Bilirubin TC MatrixTECO DIAGNOSTICSCIG2023-07-21
10673486001297Teco Diagnostics Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
10673486001303Teco Diagnostics Direct and Total Bilirubin Reagent SetTECO DIAGNOSTICSCIG2023-07-21
00852169008317ClearChem Diagnostics Inc. Total BilirubinCLEARCHEM DIAGNOSTICS INC.CIG2023-01-20
00852169008324ClearChem Diagnostics Inc. Direct BilirubinCLEARCHEM DIAGNOSTICS INC.CIG2023-01-20
00811727015952Pointe Total Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00811727016133Pointe Direct Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00811727016256Pointe Total Bilirubin ReagentHORIBA INSTRUMENTS INCORPORATEDCIG2021-01-30
00842768014192Dimension® Flex® reagent cartridge URCASiemens Healthcare Diagnostics Inc.CIG2020-09-24
03610230006870Yumizen C1200 Direct BilirubinHORIBA ABX SASCIG2020-08-28
03610230006887Yumizen C1200 Total BilirubinHORIBA ABX SASCIG2020-08-28
00811727015822Pointe Direct Bilirubin for BS480HORIBA INSTRUMENTS INCORPORATEDCIG2020-05-28
00380740174965ARCHITECTAbbott GmbHCIG2020-04-12
00380740174972ARCHITECTAbbott GmbHCIG2020-04-12
07613336164884Direct BilirubinRoche Diagnostics GmbHCIG2020-03-13