FDA.reportPublic FDA data

Synchron

Primary DI
15099590193218
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
A15625
Catalog number
A15625
Device description
HDL Cholesterol Reagent HDL 2 x 200
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
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142985000UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26JIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590193218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959019321815099590193218

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of high density lipoprotein (HDL) cholesterol lipid in a clinical specimen, using an enzyme 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
00850053916250IDG/SanzayIDG/SANZAY CorporationLBS2024-06-25
00893038002890Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002913Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002920Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002937Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
04050598010437ox-LDL ELISAImmundiagnostik AGLBS2023-06-21
04050598010444ox-LDL ELISAImmundiagnostik AGLBS2023-06-21
05055273201185DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208412DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208481DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
00630414610832Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
00630414305059Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
04015630926879HDL-Cholesterol plus 3rd generationRoche Diagnostics GmbHLBS2021-02-08
00630414508436ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414551784ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414596204Atellica™ CH D-HDLSiemens Healthcare Diagnostics Inc.LBS2020-09-24
10758750001668VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
10758750002825VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
00380740161484ARCHITECTAbbott GmbHLBS2020-03-21
07613336121306HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2020-03-05
05055273208467DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2019-06-03
00386100002077HDL CHOL Reagent KitMEDICA CORPORATIONLBS2019-02-14
05055273201291HDLRANDOX LABORATORIES LIMITEDLBS2018-12-24
04015630942589HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2018-12-07
00380740129989AlinityAbbott GmbHLBS2018-08-08
00380740129996AlinityAbbott GmbHLBS2018-08-08
00380740005313ARCHITECTABBOTT LABORATORIESLBS2018-07-31
00817274022252JAS DiagnosticsDREW SCIENTIFIC, INC.LBS2018-06-04
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18