FDA.reportPublic FDA data

HDL Ultra Cholesterol

Primary DI
00628063400546
Brand
HDL Ultra Cholesterol
Company
SEKISUI DIAGNOSTICS, LLC
Model
6121
Catalog number
6121
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400546006280634005466280634005460628063400546

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
966812344
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

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