FDA.reportPublic FDA data

Synchron

Primary DI
15099590222642
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
683802
Catalog number
683802
Device description
ENZYMATIC BILIRUBIN REAGENT
Published
2016-08-24
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
JFMEnzymatic Method, Bilirubin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFMEnzymatic Method, BilirubinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053090000DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATORBeckman Coulter, Inc.2005-12-16JFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590222642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959022264215099590222642

GMDN Terms#

Term, Definition table
TermDefinition
Total bilirubin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total 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
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
05055273214772TOTAL BILIRUBIN 2 (T BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
05055273214796DIRECT BILIRUBIN 2 (D BIL 2)RANDOX LABORATORIES LIMITEDJFM2022-10-04
00630414595801Atellica CH DBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-26
00630414595818Atellica CH TBil_2Siemens Healthcare Diagnostics Inc.JFM2017-12-21
00630414513058ADVIA® Chemistry Total Bilirubin_2 TBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513065ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513072ADVIA® Chemistry TBIL_2 Total Bilirubin_2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00630414513089ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 ReagentsSiemens Healthcare Diagnostics Inc.JFM2016-09-24
00657498000564Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498000588Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001486Sirrus® Total Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
00657498001493Sirrus® Direct Bilirubin LiquiColor®STANBIO LABORATORY, L.P.JFM2016-09-23
05055273208306T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208313D BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208320D BILRANDOX LABORATORIES LIMITEDJFM2016-09-16
05055273208337T BILRANDOX LABORATORIES LIMITEDJFM2016-09-16